EUROPEAN COMMISSION
DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY
Directorate B - Health systems, medical products and innovation
B4 – Medical products: quality, safety, innovation
SUMMARY OF THE 2022 ANNUAL REPORTING
OF SERIOUS ADVERSE REACTIONS AND EVENTS
FOR BLOOD AND BLOOD COMPONENTS
(DATA COLLECTED FROM 01/01/2021 to 31/12/2021
AND SUBMITTED TO THE EUROPEAN COMMISSION IN 2022)
1
Table of Contents
1. INTRODUCTION ............................................................................................................................... 5
2. EXECUTIVE SUMMARY.................................................................................................................... 6
3. DATA COLLECTION AND ANALISYS ................................................................................................. 7
4. MAJOR FINDINGS............................................................................................................................ 7
4.1 Data completeness ....................................................................................................................... 7
4.2 Denominators ............................................................................................................................... 7
4.2.1 Number of blood collections .................................................................................................. 7
4.2.2 Number of blood component units issued............................................................................. 8
4.2.3 Number of blood component units transfused...................................................................... 9
4.2.4 Number of blood component units issued and transfused by country ............................... 10
4.2.5 Number of recipients transfused ......................................................................................... 11
4.3 Serious adverse reactions in recipients ..................................................................................... 13
4.3.1 General information ............................................................................................................. 13
4.3.2 Incidence of SAR by type of blood component .................................................................... 16
4.3.3 SAR by type of reaction ........................................................................................................ 17
4.3.4 Transfusion-related deaths .................................................................................................. 18
4.3.4.1 Type of SAR associated with death ............................................................................... 18
4.3.4.2 Death investigation ....................................................................................................... 19
4.3.5 International benchmarking ................................................................................................. 19
4.4 Serious adverse events ............................................................................................................... 21
4.4.1 General information ............................................................................................................. 21
4.4.2 Incidence of SAE ................................................................................................................... 23
4.4.3 SAE by activity step............................................................................................................... 24
4.4.4 SAE by type of event............................................................................................................. 25
4.5 Severe adverse reactions in donors ........................................................................................... 27
5. CONCLUSIONS ............................................................................................................................... 30
2
List of figures
Figure 1. Whole blood, apheresis and total number of collections: 2013-2021 comparative data ........ 8
Figure 2. Units issued per blood component type (absolute values and percentage); data 2021 .......... 9
Figure 3. Units transfused per blood component (absolute values and percentage); data 2021 ........... 9
Figure 4. Number of units issued and transfused by country (in millions); data 2021 .......................... 11
Figure 5. Recipients transfused per blood component; data 2021........................................................ 11
Figure 6. Number of blood units issued per 1 000 population; data 2021 ............................................ 12
Figure 7. Number of blood units transfused per 1 000 population; data 2021 ..................................... 12
Figure 8. Number of SAR and fatalities by imputability level and by type of blood component; data
2021 ....................................................................................................................................................... 14
Figure 9. Data on SAR by blood component type; data 2021 ............................................................... 14
Figure 10. Number of SAR of imputability level 1-3 by country and type of blood component; data
2021 ....................................................................................................................................................... 15
Figure 11. Number of SAR of imputability level 2-3 by country and type of blood component; data
2021 ....................................................................................................................................................... 15
Figure 12. Distribution of SAR by type of reaction; data 2021 .............................................................. 17
Figure 13. Distribution of SAR classified as “Others”, by subtype of other reaction; data 2021........... 17
Figure 14. Deaths by SAR type (imputability level 2-3) in absolute values and percentages; data 2021
............................................................................................................................................................... 19
Figure 15. Deaths by type of SAR (imputability level 1) in absolute values and percentages; data 2021
............................................................................................................................................................... 19
Figure 16. Total number of blood units processed: 2015-2021 comparative data ............................... 21
Figure 17. Number of SAE by country; data 2021 ................................................................................. 22
Figure 18. Number of SAE by collection type; data 2021 ...................................................................... 22
Figure 19. Incidence of SAE per 100 000 units processed; data 2021 ................................................... 24
Figure 20. Distribution of SAE by activity step (absolute numbers and percentage); data 2021 .......... 24
Figure 21. Percentage of SAE reported for activity steps other than the ten steps listed in the Common
Approach, Annex II; data 2021 .............................................................................................................. 25
Figure 22. Distribution of SAE by type (absolute numbers and percentages); data 2021..................... 25
Figure 23. Distribution by activity step of SAE classified as human error; data 2021 ........................... 26
Figure 24. SAE by type and by country; data 2021 ................................................................................ 26
Figure 25. SAR in donors (absolute numbers): 2015-2021 comparative data....................................... 27
Figure 26. Incidence of SAR in donors per 100 000 collections (absolute numbers); data 2021 ........... 27
Figure 27. SAR in donors during whole blood collection (absolute numbers and percentages); data
2021 ....................................................................................................................................................... 28
Figure 28. SAR in donors during apheresis collection (absolute numbers and percentages); data 2021
............................................................................................................................................................... 28
Figure 29. Number of SAR in donors by type (whole blood collection); data 2021 ............................... 29
Figure 30. Number of SAR in donors by type (apheresis collection); data 2021 ................................... 29
3
List of tables
Table 1. Number of units issued and transfused by country (in millions); data 2021 ........................... 10
Table 2. Incidence (number of units transfused per million population by blood component and by
country); data 2021 ............................................................................................................................... 13
Table 3. Incidence of SAR by type of blood component; data 2021 ...................................................... 16
Table 4. Number of SAR (Imputability levels 2-3) by type of reaction and blood component; data 2021
............................................................................................................................................................... 18
Table 5. Incidence of SAE per 100 000 units processed; data 2021 ...................................................... 23
List of annexes
Annex 1. Case reports on fatalities (findings of investigation) .............................................................. 31
Annex 2. Overview of the 2018 - 2022 SARE reporting exercises (2017 - 2021 data)…………………….……32
Annex 3: Annual comparison (Years of exercises 2013-2022): number of units
issued/transfused/recipients ................................................................................................................. 32
Annex 4: Annual comparison (Years of exercises 2013-2022): SAR (1-3), SAR (2-3),
SAE, SAR in donors ................................................................................................................................. 34
Annex 5: Annual comparison (Years of exercises 2013-2022): number of deaths (2-3)........................ 35
4
1. INTRODUCTION
Every year millions of European citizens benefit from blood transfusion as a result of different medical
procedures supported by many healthcare specialties. However, the use of any substance of human
origin carries some risk, particularly the possible transmission of diseases from the donor,
incompatibilities or other potential adverse effects to the recipient.
These risks can be controlled and minimised by the application of a comprehensive set of safety and
quality measures as laid down in the EU Blood legislation. Despite these measures, rare adverse events
can occur and, in line with the legislation 1, these must be identified and reported at national and EU
level (when appropriate) through national haemovigilance and surveillance systems. For the purpose
of promoting an internationally harmonised approach to reporting such unintended events, the
legislation defines Serious Adverse Reactions (SAR) as incidents observed during or after transfusion,
which may be attributable to the quality and safety of blood components and where actual harm to a
donor or recipient has occurred. Serious Adverse Events (SAE) are incidents which may affect the
quality or safety of blood and blood components with a risk of harm, but where no harm has ultimately
occurred.
In line with obligations defined in the EU legislation, 2 EU member states submit an annual report to
the European Commission (hereinafter referred to as “the Commission”) on the SAR which occurred
in recipients of blood and blood components, and SAE which occurred at any stage in the chain from
donation to clinical application. Since 2012, this report has also included information on SAR in donors
of blood and blood components, submitted on a voluntary basis.
In 2021, the Serious Adverse Reactions and Events (SARE) exercise was conducted via an online form
for the first time; the Vigilance Expert Subgroup (VES), made up of representatives nominated by
National Competent Authorities (NCAs), helped the Commission to test this new online reporting form,
and the VES subgroup for SARE reporting improvement contributed to updating the Common Approach
document with user instructions on how to submit data via the form.
This report summarises SARE data for the year 2021 submitted to the Commission by 30 European
countries and includes major findings, general conclusions and trends in European transfusion services
in terms of SARE occurrence and distribution (by category and type).
1 Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the
Council as regards traceability requirements and notification of serious adverse reactions and events.
2 Article 8 of Directive 2005/61/EC provides that member states shall submit to the Commission an annual report, by 30 June
of the following year, on the notification of serious adverse reactions and events (SARE) received by the competent authority
using the formats in Part D of Annex II and C of Annex III.
5
2. EXECUTIVE SUMMARY
The main findings for 2021 are listed below:
• Similar to the previous year, 30 countries comprising 26 EU member states plus Iceland,
Liechtenstein, Norway and the United Kingdom (Northern Ireland) contributed to the SARE
exercise 3.
• Of these, 23 countries indicated completeness of data, six indicated 75-99% completeness and
one country indicated unspecified data completeness.
• Across the 30 countries, over 20.6 million units of blood or blood components were issued for
transfusion (compared to 22.1 million in 2020). The data on recipients (reported by only 19
countries) indicates that more than 2.9 million patients received at least one transfusion.
• In total, 2 814 SAR in recipients (imputability levels 1-3) were reported by 27 countries.
However, only 1 379 SAR were likely, probably or certainly caused by the transfusion
(imputability level 2 or 3). This number is slightly lower than in the previous reporting year (2
967), which can be explained by the fact that the United Kingdom (UK), previously a major
contributor, ceased reporting as a whole in 2021 following its withdrawal from the EU.
• Febrile non-haemolytic transfusion reaction (FNHTR) (24.2%) was the most commonly
reported type of SAR, followed by anaphylaxis/hypersensitivity (15.7%) and transfusion-
associated circulatory overload (TACO) (13.4%).
• There were 25 deaths classified as probably or certainly caused by transfusion (imputability
level 2 or 3). According to the data provided, some of these transfusion-related deaths could
not be directly attributed to the quality and safety of blood components, but rather to lapses
in clinical practice or unpredictable reactions. However, only three countries provided final
investigation results on reported deaths (Belgium, France and Poland), while most
investigation results were missing, incomplete or unclear, making it impossible to know if
these deaths were preventable and what lessons, if any, could have been learned.
• In total, 2 734 SAE were reported by 24 countries, indicating a slight decrease compared to the
previous year (3 018). Similar to SAR, the decrease was due to the UK no longer reporting as a
whole. Three quarters of all SAE were reported by only four countries (Romania, Belgium,
France and Germany), so it is important to note that SAE reporting rates vary considerably
between countries. The majority of SAE were attributed to component defect (38%), followed
by human error (35%) and system failure (12%). This represented a change compared to the
previous year, when human error (44%) and system failure (29%) were the leading types of
SAE. Of the SAE classified as component defects, 73% were attributed to post-donation
(information not known at the time of donation), donor selection and testing-related events.
• Data on SAR in donors (2 946) were voluntarily reported by 23 countries (5 less than the
previous year) indicating a 26% decrease in reported SAR among blood donors compared with
the previous year, which reflects the lower number of reporting countries.
3
Greece provided the DG SANTE report after the deadline; data was not included in the analysis.
6
3. DATA COLLECTION AND ANALISYS
This report provides a summary of the national data submitted to the Commission by 26 EU member
states plus Iceland, Liechtenstein, Norway and Northern Ireland pertaining to the reporting period
from 1 January to 31 December 2021. It also includes a comparison with the data from previous years
and general conclusions.
In 2021, the Commission provided NCAs with improved tools to facilitate a standardised online data
reporting approach:
1) An electronic reporting template for national data collection and submission to a
DG SANTE-hosted database.
2) The Common Approach, version 2022 complementing the electronic reporting template with
a definition of reportable SAR and SAE, an updated recommendation on reporting
methodology and other clarifications.
The reporting countries and VES verified the accuracy of EDQM’s analysis and interpretation of SARE
data for 2021.
4. MAJOR FINDINGS
4.1 Data completeness
The annual data on SARE for blood and blood components were reported by 26 EU member states and
four non-EU countries (Iceland, Liechtenstein, Norway and Northern Ireland) comprising aggregated
data from 3 307 reporting blood establishments. The UK ceased reporting as a whole in 2021 (the first
year post Brexit), which explains the reduction in the number of establishments compared to 2020.
Regarding data completeness, 23 out of 30 reporting countries confirmed 100% completeness of
national data, while six countries provided 75-99% of the expected data. One country was not able to
provide information on completeness of national data. Similar to previous years, not all countries were
able to provide complete data on all denominators (i.e. blood units issued, blood units transfused and
number of recipients), which affected the analysis and reliability of results. Therefore, this report
provides a partial insight into SARE related to blood/blood components, rather than a comprehensive
view of the safety and quality of European transfusion services.
Iceland, Liechtenstein, Norway and Northern Ireland submitted their national data on a voluntary
basis, thus contributing to a broader picture of the quality and safety of European transfusion services.
4.2 Denominators
4.2.1 Number of blood collections
Twenty-eight countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IS, IE, IT, LV, LT, LU, MT, NL, NO, PL,
PT, RO, SK, SI, ES, SE, and NI) reported a total of 16 242 768 whole blood collections in 2021. This was
similar to the previous year when 16 510 040 collections were reported by 26 countries.
7
In terms of apheresis collection, 27 countries (all of the above except SE) reported a total of 6 035 995
collections.
26,000,000
25,278,429 24,086,899
23,738,202
23,638,847 23,196,776
22,562,362 22,278,763
22,012,443
21,000,000
19,817,598
18,580,777 18,213,325
17,866,384
16,949,449 17,174,443 17,407,743
16,510,040 16,242,768
15,353,382
16,000,000
11,000,000
5,460,831 5,506,122 5,524,877 5,772,463 5,789,033 5,502,403 6,035,995
6,000,000
5,387,919
1,596,067
1,000,000
2013 2014 2015 2016 2017 2018 2019 2020 2021
-4,000,000
Whole blood collections Apheresis collections Total
Figure 1. Whole blood, apheresis and total number of collections: 2013-2021 comparative data
4.2.2 Number of blood component units issued
Regarding the units of blood components issued, 25 countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR,
DE, IS, IT, LV, LT, LU, MT, NL, PL, PT, RO, SK, SI, SE and NI) provided data. Four of the remaining countries
(DE, ES, LI and NO) did not report the number of units issued but did provide the number of units
transfused. As in previous exercises, it is considered that all units transfused must have previously been
issued, hence the numbers for units transfused have been included in the total number of units
reported as issued.
A total of 20 633 199 issued units of blood and blood components were reported in 2021. Figure 2
shows a breakdown of units issued by type of blood component (including data on transfused units
from DE, ES, LI and NO). Where possible, the number of units of COVID-19 Convalescent Plasma (CCP)
(5 906 units) were excluded from the total number of units of plasma issued.
8
Plasma (2,598,589) Whole blood (3,265)
12% 0%
Platelets
(2,422,663)
12%
RBC (15,608,682)
76%
Figure 2. Units issued per blood component type (absolute values and percentage); data 2021
4.2.3 Number of blood component units transfused
Concerning the units of blood components transfused, a total of 17 808 869 units were reported as
transfused by 26 countries (AT, BE, BG, HR, CY, CZ, DK, EE, FR, DE, HU, IS, IE, IT, LV, LI, LU, MT, NL, NO,
PT, RO, SK, ES, SE, and NI). Where data on CCP were provided, those units were subtracted from the
total number of plasma units transfused (4 909 CCP units).
Plasma Whole blood (2,999)
(2,272,341) 0%
13%
Platelets
(2,158,095)
12%
RBC (13,375,434)
75%
Figure 3. Units transfused per blood component (absolute values and percentage); data 2021
9
4.2.4 Number of blood component units issued and transfused by country
The number of units issued and transfused as reported by each country is presented in Table 1. Where
only the number of units transfused was reported (DE, ES, LI and NO), the units transfused were
considered as units issued on the principle that the number of blood components issued was greater
than or equal to the number of units transfused (only issued products are suitable for transfusion). The
same data (in millions) is represented graphically in Figure 4.
Country Number of units Number of units
issued transfused
Austria (AT) 323 548 313 628
Belgium (BE) 518 514 512 521
Bulgaria (BG) 238 582 197 206
Croatia (HR) 256 870 245 223
Cyprus (CY) 87 467 84 050
Czechia (CZ) 569 628 567 467
Denmark (DK) 254 611 255 219
Estonia (EE) 63 869 62 349
Finland (FI) 211 621 N/A
France (FR) 3 005 234 2 817 261
Germany (DE) 4 983 716 4 983 716
Hungary (HU) 535 512 214 322
Iceland (IS) 14 552 13 389
Ireland (IE) 145 501 144 185
Italy (IT) 2 964 204 2 885 769
Latvia (LV) 92 038 91 115
Liechtenstein (LI) 221 221
Lithuania (LT) 127 126 N/A
Luxembourg (LU) 24 237 23 785
Malta (MT) 23 059 17 892
Netherlands (NL) 457 317 440 791
Norway (NO) 212 938 212 938
Poland (PL) 1 556 981 N/A
Portugal (PT) 372 143 352 078
Romania (RO) 674 654 655 704
Slovakia (SK) 341 234 341 234
Slovenia (SI) 101 897 N/A
Spain (ES) 1 883 734 1 883 734
Sweden (SE) 543 175 447 945
Northern Ireland (NI) 49 016 45 127
Total 20 633 199 17 808 869
Table 1. Number of units issued and transfused by country (in millions); data 2021
10
5.00
4.50
4.00
3.50
3.00
2.50
2.00
1.50
1.00
0.50
0.00
Cyprus (CY)
Germany (DE)
Ireland (IE)
Bulgaria (BG)
Liechtenstein (LI)
Malta (MT)
Netherlands (NL)
Romania (RO)
Denmark (DK)
France (FR)
Croatia (HR)
Iceland (IS)
Lithuania (LT)
Luxembourg (LU)
Northern Ireland (NI)
Austria (AT)
Belgium (BE)
Czechia (CZ)
Estonia (EE)
Finland (FI)
Poland (PL)
Slovenia (SI)
Hungary (HU)
Italy (IT)
Latvia (LV)
Norway (NO)
Portugal (PT)
Slovakia (SK)
Spain (ES)
Sweden (SE)
Units issued (million) Units transfused (million)
Figure 4. Number of units issued and transfused by country (million); data 2021
4.2.5 Number of recipients transfused
According to data reported by 19 countries (AT, BE, BG, HR, CY, CZ, DK, ES, FR, IS, IE, IT, LI, LU, MT, NI,
NL, PT, and SE), 2 752 465 patients were transfused in 2021 (Figure 5). In addition, Romania reported
159 842 recipients for whom for the type of blood component transfused was not specified.
When interpreting these results, be advised that they do not reflect the fact that a given patient might
have received more than one blood component; these patients were counted more than once.
Plasma (246,949) Whole blood (1,080)
9% 0%
Platelets (278,050)
10%
RBC (2,226,386)
81%
Figure 5. Recipients transfused per blood component; data 2021
Considering the demographic data of the reporting countries as of 1 January 2021 44, the incidence of
issued and transfused blood components per 1 000 population is presented in Figures 6 and 7.
4
https://ec.europa.eu/eurostat/web/population-demography/demography-population-stock-balance/database;
https://www.nisra.gov.uk/publications/census-2021-table-lookups (Following Brexit, UK = Northern Ireland only)
11
Austria (AT) 36
Belgium (BE) 45
Bulgaria (BG) 34
Croatia (HR) 64
Cyprus (CY) 98
Czechia (CZ) 54
Denmark (DK) 44
Estonia (EE) 48
Finland (FI) 38
France (FR) 44
Germany (DE) 60
Hungary (HU) 55
Iceland (IS) 39
Ireland (IE) 29
Italy (IT) 50
Latvia (LV) 49
Liechtenstein (LI) 6
Lithuania (LT) 45
Luxembourg (LU) 38
Malta (MT) 45
Netherlands (NL) 26
Norway (NO) 39
Poland (PL) 41
Portugal (PT) 36
Romania (RO) 35
Slovakia (SK) 62
Slovenia (SI) 48
Spain (ES) 40
Sweden (SE) 52
Northern Ireland (NI) 26
-10 10 30 50 70 90 110
Figure 6. Number of blood units issued per 1 000 population; data 2021
Austria (AT) 35
Belgium (BE) 44
Bulgaria (BG) 29
Croatia (HR) 61
Cyprus (CY) 94
Czechia (CZ) 54
Denmark (DK) 44
Estonia (EE) 48
France (FR) 42
Germany (DE) 60
Hungary (HU) 22
Iceland (IS) 36
Ireland (IE) 29
Italy (IT) 49
Latvia (LV) 48
Liechtenstein (LI) 6
Luxembourg (LU) 37
Malta (MT) 35
Netherlands (NL) 25
Norway (NO) 39
Portugal (PT) 34
Romania (RO) 34
Slovakia (SK) 62
Spain (ES) 40
Sweden (SE) 43
Northern Ireland (NI) 24
0 10 20 30 40 50 60 70 80 90 100
Figure 7. Number of blood units transfused per 1 000 population; data 2021
12
The incidence of blood component units transfused (per million population), calculated for each
reporting country, is presented in Table 2 below. Countries that did not provide data for at least one
type of component were not included.
Red blood cells Platelets Plasma Whole blood
Number of units Number of units Number of units Number of units
Country transfused (pmp) transfused (pmp) transfused (pmp) transfused (pmp)
Austria (AT) 30 923 3 841 346
Belgium (BE) 34 949 5 668 3 739
Bulgaria (BG) 14 886 3 576 10 047 2.9
Croatia (HR) 43 451 7 020 10 283
Cyprus (CY) 72 168 6 615 15 022
Czechia (CZ) 40 109 4 474 9 355 133.0
Denmark (DK) 31 226 6 067 6 409
Estonia (EE) 33 495 5 282 8 094 4.5
France (FR) 33 422 4 945 3 272 2.0
Germany (DE) 42 279 7 165 10 489
Iceland (IS) 27 091 5 564 3 650
Ireland (IE) 24 328 4 472 0.2
Italy (IT) 40 747 3 999 3 970 0.3
Latvia (LV) 28 310 4 500 15 317
Liechtenstein (LI) 5 505 77 77
Luxembourg (LU) 28 789 4 881 3 803
Malta (MT) 26 985 3 893 3 790
Netherlands (NL) 22 225 2 957 42
Norway (NO) 27 450 4 406 7 538 102.6
Portugal (PT) 28 139 4 939 1 109 1.0
Romania (RO) 18 258 5 579 10 270 41.4
Slovakia (SK) 37 606 4 425 20 469
Spain (ES) 31 962 4 853 2 927 0.2
Sweden (SE) 35 013 4 509 3 631 4.3
Northern Ireland (NI) 18 747 3 197 1 767
Table 2. Incidence (number of units transfused per million population by blood component and by
country); data 2021
4.3 Serious adverse reactions in recipients
4.3.1 General information
The incidence of SAR in 2021 was 7.3 per 100 000 units transfused (see section 4.3.2). Although the
result suggests a decrease in SAR incidence compared to the previous year (8.99), it is important to
keep in mind when interpreting these data that they are incomplete and inconsistent across the
reporting countries in terms of denominators and SAR reporting.
Twenty-five SAR (imputability 2-3) resulted in death. In terms of the type of blood component
involved, 19 fatalities were associated with red blood cell (RBC) transfusion (76%), four with platelet
transfusion (16%) and two with transfusion of more than one blood component (8%).
13
A summary of this is presented in Figure 8. SAR from countries that did not report the number of units
transfused were excluded.
2,999 2 2 2
100% 45 2 43 78
2,272,341 149 238
90% 149
2,158,095 4
80% 571
70% 356 352
60%
50%
40% 13,375,434 19
1600
30% 697 680
20%
10%
0%
Units Total SAR (level Death (level No Death (level Total SAR
transfused 2+3) 2+3) 2+3) (level 1-3)
Red blood cells Platelets
Plasma Whole blood
More than one blood component transfused
Figure 8. Number of SAR and fatalities by imputability level and by type of blood component; data 2021
The majority of the reported SAR (level 2 or 3) were associated with transfusions of RBC, followed by
platelets and plasma. The percentage of SAR by type of blood component is presented in Figure 9.
More than one blood
Whole blood (2)
component (45)
0%
3%
Plasma (180)
13%
Red Blood Cells (762)
55%
Platelets (390)
29%
Figure 9. Data on SAR by blood component type; data 2021
The distribution of SAR imputability 1-3 and 2-3 by country and by blood component is represented in
Figures 10 & 11.
14
100% 1 8 1
32 2 1 1 4 1
1 15 20 144 12
17 3 2
90% 3 1
5 4 16 61 9
10 8 24 6
4 8 89 7
80% 1
6 21
7
2 34 328 1
70% 2 4
2 3 2 9 21
53
60% 8
2 6
50% 1 1
8 10
102
40%
1 398 23
14 23 54 71 23 9
15 3
30% 9 8 66 17 702 35
7 127 38
5
20%
6 1
5
10%
0%
Red Blood Cells Platelets Plasma Whole blood More than one blood component transfused
Figure 10. Number of SAR of imputability level 1-3 by country and type of blood component; data 2021
100% 3
15 2 1 4
1 6 1
90% 3 1 11 5 99 3 1
14 3 3 15 9
5 16 6
80% 29 20 5
1 7 2
1 1 8 16
70%
24 21
205 2 4
60%
2 8 18
7 6
50% 1
7 5
40% 55
9 9 131 14
4 36 23 3
30% 30
9 29 38
7 35 274 29 2
20% 4
5 1
10%
5
0%
Red Blood Cells Platelets Plasma Whole blood More than one blood component transfused
Figure 11. Number of SAR of imputability level 2-3 by country and type of blood component; data 2021
15
4.3.2 Incidence of SAR by type of blood component
As shown in Table 3, the risk associated with the transfusion of platelets is significantly higher
compared to other blood components (based on data from those countries who provided the number
of SAR and units transfused, per type of blood component). SAR from countries that did not report the
number of units transfused have not been included (FI, LT, PL and SI).
The incidence of SAR associated with transfusion of platelets (number of SAR associated with the
transfusion of platelets per 100 000 units of platelets transfused) was 17.3, 7.2 for plasma and 5.4 for
RBC.
SAR (2+3)
Deaths
incidence Deaths Percentage of
Units Total SAR Total SAR incidence (per
Component type (per 100 000 (level deaths among
transfused (level 1-3) (level 2+3) 100 000 units
units 2+3) SAR 2-3
transfused)
transfused)
Red blood cells 13 375 434 1 718 724 5.4 19 2.6% 0.14
Platelets 2 158 095 623 374 17.3 4 1.1% 0.18
Plasma 2 272 341 298 164 7.2 0 0% 0
Whole blood 2 999 2 2 66.7 0 0% 0
More than one
blood component - 76 43 NA 2 4.6% NA
transfused
Total 17 808 869 2 717 1 307 7.3 25 1.7% 0.13
Table 3. Incidence of SAR by type of blood component; data 2021
As some participating countries reported partial data, the interpretation of these results should take
into consideration this limitation.
16
4.3.3 SAR by type of reaction
According to the classification in Figure 12, the most common type of SAR was FHTR (24.2%), followed
by anaphylaxis/hypersensitivity (15.7%) and TACO (13.4%).
Other 412
Febrile non-haemolytic transfusion 334
Anaphylaxis/hypersensitivity 217
TACO 185
Immunological Haemolysis 116
TAD 41
TRALI 38
Hypotensive transfusion reaction 14
Transfusion-transmitted bacterial infection 11
Transfusion-transmitted viral infection 4
Post-transfusion purpura 3
Non-immunological Haemolysis 3
Transfusion associated graft versus host disease 1
Transfussion-transmitted prion infection 0
Transfusion-transmitted fungal infection 0
Transfusion-transmitted parasitical infection 0
0 50 100 150 200 250 300 350 400 450
Figure 12. Distribution of SAR by type of reaction; data 2021
As was the case in previous years, unclassified SAR remains the most prevalent group (30%). A
detailed account of the types of reactions in recipients classified as “others” is available in Figure 13.
Greater clarification is required here in order to address the potential issue of classification accuracy.
Allergic reaction 318
Other without specifications 53
Delayed haemolytic transfusion reaction (DHTR) 11
Fever + other symptoms 5
Respiratory disorders (other than TRALI) 2
Hypertension 2
Fever 2
Dyspnea + other symptoms 2
Cannot conclude 2
Urticarial rash 1
Mild allergic reactions 1
Low grade pyrexia, hypotension, chills,GI symptoms, dizziness 1
Increased respiratory rate, bilateral crepitations, signs of… 1
Hypertension + other symptoms 1
Hemosiderosis 1
Auto immune haemolytic anemia aggravated by transfusion 1
0 50 100 150 200 250 300 350
Figure 13. Distribution of SAR classified as “Others”, by subtype of other reaction; data 2021
17
A detailed presentation of SAR (imputability level 2-3) by type of reaction and type of blood
component is available in Table 4 below.
More than
Red blood one blood
Plasma Platelets Whole blood
cells component All
SAR Type (Level 2+3) transfused
No No No No No
Death Death Death Death Death No
Death death Death Death Death Death Death Total
Anaphylaxis/hypersensitivity 57 1 47 0 98 0 0 0 15 0 217 0 217
Immunological haemolysis due
to ABO incompatibility 44 8 6 0 3 0 1 0 1 0 55 8 63
Immunological haemolysis due
to other allo-antibody 49 2 0 0 1 0 0 0 0 1 50 3 53
Non-immunological haemolysis 3 0 0 0 0 0 0 0 0 0 3 0 3
Post-transfusion purpura 1 0 1 0 0 0 0 0 1 0 3 0 3
Transfusion-related acute lung
injury (TRALI) 19 0 7 0 5 1 0 0 5 1 36 2 38
Transfusion-transmitted
bacterial infection 1 0 0 0 6 3 0 0 1 0 8 3 11
Transfusion-transmitted
parasitical infection 0 0 0 0 0 0 0 0 0 0 0 0 0
Transfusion-transmitted fungal
infection 0 0 0 0 0 0 0 0 0 0 0 0 0
Transfusion-transmitted viral
infection 2 0 0 0 1 0 0 0 1 0 4 0 4
Transfusion-associated graft-
versus-host disease 0 0 0 0 0 0 0 0 1 0 1 0 1
TACO 156 8 4 0 6 0 0 0 11 0 177 8 185
Febrile non-haemolytic
transfusion 240 0 8 0 81 0 0 0 5 0 334 0 334
TAD 26 0 3 0 11 0 1 0 0 0 41 0 41
Hypotensive transfusion
reaction 10 0 1 0 3 0 0 0 0 0 14 0 14
Other 135 1 103 0 171 0 0 0 2 0 411 1 412
Total 743 20 180 0 386 4 2 0 43 2 1 354 25 1 379
Table 4. Number of SAR (Imputability levels 2-3) by type of reaction and blood component; data 2021
4.3.4 Transfusion-related deaths
4.3.4.1 Type of SAR associated with death
Out of 25 transfusion-related deaths, the majority were associated with TACO (8), followed by
immunological haemolysis (11), bacterial infection (3) and TRALI (2):
• TACO (8) - following RBC transfusion
• Immunological haemolysis (11) - following RBC transfusion and due to other alloantibodies
• Bacterial infection (3) – non-specified bacterial infections transmitted via platelet transfusion
• TRALI (2) - following platelet transfusion (1) and more than one component transfusion (1)
• Other (1) - uncategorised adverse reaction following RBC transfusion
18
TACO 8
Immunological Haemolysis due to ABO incompability 8
Transfusion-transmitted bacterial infection 3
Immunological Haemolysis due to other allo-antibody 3
Transfusion related acute lung injury (TRALI) 2
Other 1
0 1 2 3 4 5 6 7 8 9
Figure 14. Deaths by SAR type (imputability level 2-3) in absolute values and percentages; data 2021
In addition, 23 deaths with imputability level 1 were voluntarily reported by 13 countries (BE, FI, FR,
DE, ES, HU, LU, NI, NL, NO, PL, PT, RO and ES), 52% of which were associated with TACO, as shown in
Figure 15.
TACO 12
Anaphylaxis/hypersensitivity 3
Other 2
Transfusion related acute lung injury (TRALI) 2
Immunological Haemolysis due to ABO incompability 2
TAD 1
Immunological Haemolysis due to other allo-antibody 1
0 2 4 6 8 10 12 14
Figure 15. Deaths by type of SAR (imputability level 1) in absolute values and percentages; data 2021
4.3.4.2 Death investigation
Out of the 25 SAR that resulted in death, investigation results were provided for only three deaths by
Belgium, France and Poland. The case reports (original text) are available in Annex 1.
4.3.5 International benchmarking
This summary of SARE reports from European countries presents a set of indicators that span the
transfusion chain from donor to recipient, and provides an insight, albeit not comprehensive, into
haemovigilance practices across Europe and at the level of individual countries.
According to WHO’s Global Status Report on Blood Safety and Availability 5, Europe was the WHO
region that had the highest percentage of countries with a national haemovigilance system in place
(81%).
5
WHO Global Status Report on Blood Safety and Availability https://www.who.int/publications/i/item/9789240051683
19
Results on SAR, as well as practical solutions derived from lessons learned by other jurisdictions across
the world where well-established systems are in place, were consulted. Relevant data from the
Australian, Canadian and Japanese national reports are presented below.
According to the Australian Haemovigilance Report 2019-2020 published by the National Blood
Authority 6, 61.5% of adverse events were related to red cell transfusions, followed by platelets (24.7%)
and fresh frozen plasma (10.2%). Out of 326 transfusion-related SAE reported in the period 2015-2020,
TACO and anaphylactic reactions accounted for 52.5% of reported SAE, followed by allergic reactions
and FNHTR (17.8% and 14.4%, respectively). A breakdown of SAE by imputability score and outcome
severity indicated that four reported deaths were possibly or likely to be related to transfusion, with
two anaphylactic reactions, one TRALI and one ABO incompatibility; 40% of reported SAE (131/326)
were life-threatening, and 59% (191/326) were reported to be related to severe morbidity, including
53 TACO, 44 FNHTR and 38 allergic reactions.
The Canadian Transfusion Error Surveillance System (TESS) summary for 2020-2021 7 included 1 192
confirmed events. Of these, 13 (1.1%) caused harm in patients. These adverse transfusion reactions
caused by transfusion errors comprised TACO (46%) and 7 cases of other reactions: delayed serological
transfusion reaction (2), unspecified adverse transfusion reaction (2), FNHTR (1), severe
anaphylactic/anaphylactoid allergic reaction (1) and harm associated with transfusion delay (1).
The 2021 Haemovigilance Report by the Japanese Red Cross Society (JRCS) 8 states that SAR accounted
for 24.6% of all adverse reactions and mainly comprised severe allergy, dyspnoea, and hypotension. In
April 2021, the JRCS started evaluating TRALI and TACO cases based on new criteria (Transfusion. 2019;
59:2465-76, ISBT Working Party on Haemovigilance in collaboration with IHN and AABB.2018.).
As a safety measure against TRALI, the JRCS manufactures fresh frozen plasma (FFP) preferentially
derived from 400 mL whole blood donations from male donors. While almost 100% of FFP made from
400 mL whole blood donations are derived from male donors, less than 20% of FFP made from 200 mL
whole blood donations and 70% of FFP made from apheresis donations are derived from male donors.
Since TACO is a form of cardiac failure due to circulatory overload, it is important to understand the
patient’s potential risk of cardiac failure by measuring pre-transfusion NT-pro BNP levels or confirming
any kidney function insufficiency.
In 2021, 41 haemolytic adverse reactions were reported by medical institutions, of which 16 were
serious cases of acute reactions and 25 cases were delayed reactions.
Two cases of HBV infections were confirmed TTIs in 2021. No transfusion-transmitted HCV and HIV
cases have been confirmed since the introduction of the nucleic acid amplification test (NAT) on
individual samples.
Two cases of transfusion-transmitted bacterial infection (TTBI) involving two divided platelet units
prepared from a single apheresis donation were reported. Blood culture tests detected Morganella
morganii in a platelet component unit that was discontinued during transfusion and two recipients,
one of whom died of septic shock. Approximately 1-2 cases of TTBI involving platelet components are
confirmed every year. JRCS is planning to implement bacterial screening tests in platelet components.
6
Australian Haemovigilance Report 2019 - 2020, National Blood Authority
https://www.blood.gov.au/sites/default/files/Haemovigilance%20Report%202019-20.pdf
7
TRANSFUSION ERROR SURVEILLANCE SYSTEM (TESS), 2020-2021, Infographic https://www.canada.ca/content/dam/phac-
aspc/documents/services/surveillance/blood-safety-contribution-program/transfusion-error-surveillance-system-2020-2021-
infographic/PHAC-TESS2021-Info-EN-March1.pdf
8
Haemovigilance by JRCS 2021, Japanese Red Cross Society, Safety Vigilance Division, Technical Department, Blood Service Headquarters
https://www.jrc.or.jp/mr/english/
20
Of the nine suspected HBV infections reported in 2021, two were confirmed to be transfusion-
transmitted HBV infections, including a spontaneous report on an HBV infection that was identified
following hepatitis in the recipient and a case identified through a look-back study that was prompted
by the positive conversion of the donor on NAT testing.
4.4 Serious adverse events
4.4.1 General information
The main denominator for SAE is the total number of blood units processed. During 2021, a total of
22 961 648 blood units were processed according to data provided by 24 countries (AT, BE, BG, HR,
CY, CZ, DK, EE, ES, FI, FR, DE, IS, IE, IT, LV, NI, NL, NO, PL, PT, RO, SI and SE). An overview of data on
blood units processed over the reporting years is presented in Figure 16.
27,244,855
25,777,859 25,177,727
30,000,000 22,525,782 24,129,477 22,961,648
25,000,000 19,978,403
20,000,000
15,000,000
10,000,000
5,000,000
0
2015 2016 2017 2018 2019 2020 2021
Figure 16. Total number of blood units processed: 2015-2021 comparative data
2 734 SAE were reported in 2021 by 24 countries (AT, BE, BG, HR, CY, CZ, DK, EE, ES, FI, FR, DE, IS, IE,
IT, LV, NI, NL, NO, PL, PT, RO, SI and SE). As shown in Figure 17, the number of SAE reported varied
substantially between reporting countries, similar to previous years. It is recommended to exercise
caution when drawing conclusions from these data as 75% of SAE were reported by only four countries
(BE, FR, RO and DE).
21
Austria (AT) 11
Belgium (BE) 644
Bulgaria (BG) 1
Croatia (HR) 4
Cyprus (CY) 1
Czechia (CZ) 3
Denmark (DK) 9
Estonia (EE) 47
Finland (FI) 15
France (FR) 468
Germany (DE) 259
Iceland (IS) 3
Ireland (IE) 133
Italy (IT) 10
Latvia (LV) 2
Netherlands (NL) 81
Norway (NO) 86
Poland (PL) 37
Portugal (PT) 34
Romania (RO) 688
Slovenia (SI) 6
Spain (ES) 7
Sweden (SE) 124
Northern Ireland (NI) 61
0 100 200 300 400 500 600 700
Figure 17. Number of SAE by country; data 2021
The distribution of SAE by type of collection based on data from 16 countries (BE, CZ, DK, FI, FR, DE,
IE, IT, NI, NL, NO, PL, PT, RO, SI and SE) is represented on Figure 18. Out of 205 SAE, 76% were related
to whole blood collection and 24% to apheresis.
0 10 20 30 40 50 60 70
Belgium (BE) 2 3
Czechia (CZ) 1
Denmark (DK) 5
Finland (FI) 3
France (FR) 1 19
Germany (DE) 6 10
Ireland (IE) 11 7
Italy (IT) 11
Netherlands (NL) 73
Norway (NO) 2
Poland (PL) 4 1
Portugal (PT) 12 1
Romania (RO) 35 1
Slovenia (SI) 1
Sweden (SE) 4
Northern Ireland (NI) 1
Whole blood collection Apheresis collection
Figure 18. Number of SAE by collection type; data 2021
22
4.4.2 Incidence of SAE
SAE occur at all stages of the transfusion cycle, from donor selection to clinical services, but the only
available denominator is number of units processed, which is not optimal. Regardless, it has been used
to calculate the incidence of SAE (per 100 000 units of blood/blood components processed).
The incidence of SAE per each reporting country is presented in Table 5 and Figure 19 below.
Total number of units SAE/100 000 units
Country # SAE
processed processed
Austria (AT) 408 702 11 2.7
Belgium (BE) 638 796 644 100.8
Bulgaria (BG) 280 675 1 0.4
Croatia (HR) 189 020 4 2.1
Cyprus (CY) 66 208 1 1.5
Czechia (CZ) 1 506 077 3 0.2
Denmark (DK) 661 814 9 1.4
Estonia (EE) 51 348 47 91.5
Finland (FI) 217 802 15 6.9
France (FR) 3 008 673 468 15.6
Germany (DE) 6 496 821 259 4.0
Iceland (IS) 11 293 3 26.6
Ireland (IE) 138 338 133 96.1
Italy (IT) 3 021 143 10 0.3
Latvia (LV) 58 603 2 3.4
Lithuania (LT) 101 598 0 0.0
Luxembourg (LU) 44 181 0 0.0
Malta (MT) 16 157 0 0.0
Netherlands (NL) 760 000 81 10.7
Norway (NO) 183 592 86 46.8
Poland (PL) 1 397 355 37 2.6
Portugal (PT) 310 757 34 10.9
Romania (RO) 764 037 688 90.0
Slovakia (SK) 195 340 0 0.0
Slovenia (SI) 173 768 6 3.5
Spain (ES) 1 720 402 7 0.4
Sweden (SE) 509 025 124 24.4
Northern Ireland (NI) 43 435 61 140.4
Total 22 974 960 2 734 11.39
Table 5. Incidence of SAE per 100 000 units processed; data 2021
23
0.0 20.0 40.0 60.0 80.0 100.0 120.0 140.0
Austria (AT) 2.7
Belgium (BE) 100.8
Bulgaria (BG) 0.4
Croatia (HR) 2.1
Cyprus (CY) 1.5
Czechia (CZ) 0.2
Denmark (DK) 1.4
Estonia (EE) 91.5
Finland (FI) 6.9
France (FR) 15.6
Germany (DE) 4.0
Iceland (IS) 26.6
Ireland (IE) 96.1
Italy (IT) 0.3
Latvia (LV) 3.4
Lithuania (LT) 0.0
Luxembourg (LU) 0.0
Malta (MT) 0.0
Netherlands (NL) 10.7
Norway (NO) 46.8
Poland (PL) 2.6
Portugal (PT) 10.9
Romania (RO) 90.0
Slovakia (SK) 0.0
Slovenia (SI) 3.5
Spain (ES) 0.4
Sweden (SE) 24.4
Northern Ireland (NI) 140.4
Figure 19. Incidence of SAE per 100 000 units processed; data 2021
4.4.3 SAE by activity step
According to the Common Approach, version 2022, Annex II, SAE are classified by activity step that
includes donor selection, whole blood apheresis collection, testing, processing, storage,
distribution, component selection, compatibility testing/cross matching, issue and other.
Similar to the previous year, SAE classified as other SAE were the most represented (31%), followed
by those attributed to testing (16%), then donor selection (12%), processing (8%) and issue (8%), as
shown in Figure 20.
Donor selection (324)
12% Whole blood collection (155)
Other (850) 6%
31%
Apheresis Collection (50)
2%
Testing (435)
16%
Issue (216)
8%
Compatibility testing/ Processing (217)
Cross-matching (89) 8%
3% Component selection (116) Storage (209)
4% Distribution (73) 7%
3%
Figure 20. Distribution of SAE by activity step (absolute numbers and percentage); data 2021
24
As in 2021, there were clear discrepancies between countries in terms of how activity steps were
assigned when SAE were identified/occurred: 91% of all SAE classified as attributed to other activity
steps than the ten listed in the Common Approach, Annex II (850 SAE), were reported by two countries
(Belgium and France). This raises the question of accuracy of classifying SAE by activity step, as well as
issues of over/under reporting, but it may also be an indication that the activity steps need to be
defined in line with current processes specific to blood establishments.
100%
14
90%
80% 50 55 55
70%
74
60% 83
95 95
50%
86
40%
30% 50 45 45
20%
26
10% 17
5 5
0%
Latvia (LV) Slovenia Poland (PL) Northern Ireland (IE) Norway France (FR) Belgium
(SI) Ireland (NI) (NO) (BE)
% category "Other" % defined categories
Figure 21. Percentage of SAE reported for activity steps other than the ten steps listed in the Common
Approach, Annex II; data 2021
4.4.4 SAE by type of event
The most commonly reported SAE in 2021 were related to component defect (38%), followed by
human error (35%), system failure (12%) and equipment failure (9%).
The number of SAE classified as human error, although still high, continues to decrease every year.
This reflects the efforts made by reporting countries to adapt to the new classification suggested by
the VES, which has improved the quality of the data reported.
Over 70% of the 1 037 SAE related to component defect were reported by only two countries: Romania
and Belgium (41% and 32%, respectively). In the component defect category, Belgium included
possible or confirmed COVID-19 cases, fever and Lyme disease (Figure 22).
Other (127)
Materials (21)
5%
1% Component defect (1037)
38%
Human error (974)
35%
Equipment failure (243)
System failure (332) 9%
12%
Figure 22. Distribution of SAE by type (absolute numbers and percentages); data 2021
25
Human error occurs in all activities from donor selection to component issue. The distribution of the
947 SAE classified as human error by activity step is represented in Figure 23. The Other group included
a variety of types of SAR (data entry error, sample processing error, transcription error, incorrect
labelling of component, transfusion of invalid sample, special requirement not met, etc.).
Apheresis collection (12)
28 12
Compatibility testing/Cross matching (66)
135 17 Component selection (96)
66
21 Distribution (48)
96 Donor selection
Issue (165)
48
278 Other (278)
108 Processing (21)
Storage (135)
165
Testing (17)
Whole blood collection (28)
Figure 23. Distribution by activity step of SAE classified as human error; data 2021
A detailed representation of SAE by type for each reporting country is available in Figure 24 below.
100% 10 6 1 1
22 3 7 1
1 2 1 6
2 104 1
90% 3
1
28
80% 157
1
281 2 122 1 157 63 31
70% 6 23
2
60% 5 89
6
3 30
50% 1 1 11 10 3 1
8 73
40 5
40% 243 50
8 1
35
30% 427
338 1
2 3 1 29
20% 113 18
1 13
1
10% 2 1 24
53 17 3 2 1
1 1
5 1
0% 5 1 1
Component defect Equipment failure System failure Human error Materials Other
Figure 24. SAE by type and by country; data 2021
26
4.5 Severe adverse reactions in donors
According to Directive 200/61/EC, SAR in donors are not reportable unless they impact the quality and
safety of the blood components 9. However, as an acknowledgment the value of data on SAR in donors,
the Commission encourages member states to submit these reactions on a voluntary basis. Thus, a
specific “SAR in donors of blood or blood components” section is included in the reporting template.
In general, SAR in donors should be reported if they were certainly or probably caused by the donation
(imputability 2 or 3). However, for donor fatalities, all cases should be reported where a fatality was
possibly, probably or certainly related to the donation process (imputability 1, 2 or 3).
Twenty-three countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IS, IE, IT, LU, NL, NO, PL, PT, RO, SK,
SI and SE) reported, on a voluntary basis, a total of 2 946 SAR in donors. The comparative data from
SARE exercises in the period 2016-2022 (2015-2021 data) is presented in Figure 25.
7,769 7,658
10,000 6,239
4,635 3,821 4,025 2,946
5,000
0
2015 2016 2017 2018 2019 2020 2021
Figure 25. SAR in donors (absolute numbers): 2015-2021 comparative data
Figure 26 shows the number of SAR in donors per 100 000 collections (from those countries who
were able to provide total numbers of whole blood collections and apheresis collections).
Austria (AT) 0.7 1.3
Belgium (BE) 3.3 5.6
Bulgaria (BG) 52.9
Croatia (HR) 20.4 110.2
Cyprus (CY) 4.5
Czechia (CZ) 0.4 0.4
Denmark (DK) 10.3 2.1
Estonia (EE) 33.3 10.3
Finland (FI) 0.5
France (FR) 128.0 40.1
Germany (DE) 2.3 7.6
Iceland (IS) 715.1
Ireland (IE) 10.6 10.9
Italy (IT) 21.1 9.6
Netherlands (NL) 3.5 0.7
Norway (NO) 149.4 78.2
Poland (PL) 3.2 3.6
Portugal (PT) 4.3
Romania (RO) 12.4
Slovakia (SK) 40.4 47.0
Slovenia (SI) 19.5
Sweden (SE) 11.3
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Number of SAR per 100 000 apheresis collection Number of SAR per 100 000 WB collection
Figure 26. Incidence of SAR in donors per 100 000 collections (absolute numbers); data 2021
9
Article 5 of Directive 2005/61/EC
27
Twenty-one countries (AT, BE, BG, HR, CY, CZ, DK, EE, FI, FR, DE, IE, IT, NL, NO, PL, PT, RO, SI, SE and
SK) reported a total of 2 262 SAR in donors in relation to whole blood collection. As shown in
Figure 27, during whole blood collection, vasovagal reaction was the most common type of reaction
(79%), followed by other (14%) and nerve injury/irritation (7%).
Other (314) Nerve injury /
14% irritation (153)
Major cardiovascular 7%
event or death up to 24h
after donation (14)
0.6%
Vasovagal reaction (1781)
79%
Figure 27. SAR in donors during whole blood collection (absolute numbers and percentages); data
2021
No deaths were encountered among the 12 cases of major cardiovascular events reported by France
and Germany. No complications were associated with the two major cardiovascular events reported
by Bulgaria and Sweden.
Fifteen countries (AT, BE, HR, CZ, DK, EE, FR, DE, IS, IE, IT, NL, NO, PL and SK) reported a total of 684
SAR in donors following apheresis collection.
Three countries (CZ, FR and DE) reported four cases of major cardiovascular events with no fatalities.
Distribution of SAR in donors during apheresis collection is shown in Figure 28.
Major cardiovascular event or Nerve injury / irritation (15)
death up to 24h after donation (4) 2%
General (7)
1%
1% Citrate reaction (38)
Allergic reaction Other (130) 5%
(4) 19%
1%
Vasovagal reaction (493)
71%
Figure 28. SAR in donors during apheresis collection (absolute numbers and percentages); data 2021
The types of SAR in donors per type of collection and per country is presented in Figures 29 and 30
below. Only countries that reported SAR in donors by type of collection were included in the analysis.
28
100% 1 3 1 4
114 29 18 6 2 6
90% 1 6 3
22 1 1
80% 10 115
70%
60% 6 5
50% 4 202 3 2 5 1 34 13 92 85 30
793 217 106 13
40% 8
60 3
30% 142 2
20% 6
10% 6
6 6
0% 44 17 1 6 1
General
Other (314)
Major cardiovascular event or death up to 24h after donation (14)
Vasovagal reaction (1781)
Nerve injury / irritation (153)
Figure 29. Number of SAR in donors by type (whole blood collection); data 2021
100%
1 32
90% 1 2 5
1 1
80% 28
50 6
70%
2
60% 1
4 1
50% 1 8 1 384 6 1 3
2 18
40% 3
27 4
30% 34
2
20% 1
1
10% 6 4 1
1 1 10 2
19 5 1 1
0%
Other (130)
Major cardiovascular event or death up to 24h after donation (4)
Allergic reaction (4)
Vasovagal reaction (493)
Citrate reaction (38)
Nerve injury / irritation (15)
Figure 30. Number of SAR in donors by type (apheresis collection); data 2021
29
5. CONCLUSIONS
The SARE reporting exercises completed to date have resulted in a gradual improvement in the quality
and accuracy of the data reported. In 2021, as many as 30 European countries representing a total of
3 307 transfusion facilities submitted reports, which indicates commitment to the initiative. However,
as mentioned throughout this report, there is still a significant degree of inconsistency between
countries in terms of data reporting rates, data completeness, classification and management of
events.
Significant discrepancies between national reporting policies was also identified during the EU
legislation evaluation indicating that “the requirements for national surveillance are not sufficiently
specific and sufficiently robust, leading to divergent approaches to surveillance, reduced mutual trust
and thus barriers to trade in and access to such treatments.” 1010
In general, the major findings in this report indicate that European haemovigilance data are consistent
with known effects and expected trends, with no new safety concerns regarding blood and blood
components identified from national vigilance and surveillance programmes. However, it should be
noted that, for the reasons mentioned above, the results of analysis presented in this report should be
interpreted with caution.
10
COMMISSION STAFF WORKING DOCUMENT EXECUTIVE SUMMARY of the Evaluation of the Union legislation on blood, tissues and cells
{SWD(2019) 375 final}, Brussels, 10.10.2019 available at https://health.ec.europa.eu/system/files/2019
10/swd_2019_375_summary_en_0.pdf
30
Annex 1. Case reports on fatalities (findings of investigation)
CASE 1
A 26-year-old female patient with SCD received a transfusion of non-matched EC after miscarriage.
Evolution to (immunological) hyperhaemolysis with shock and 3 times cardiac arrest despite ICU and administration of Tocilizumab.
CASE 2
A 61-year-old female patient with a history of heart failure, chronic renal failure and adenocarcinoma of the head of the pancreas with hepatic metastasis (under palliative
chemotherapy). Hospitalized on an outpatient basis in the morning for her chemotherapy check-up. She complained of great asthenia and dyspnoea. The Hb level was 70 g/L
and the renal assessment indicated acutization of her chronic renal failure. It was decided to transfuse with two red cells units. The medical prescriber in charge of the
patient prescribed transfusion with slow flow. Weight of patient 78 kg, Blood pressure and heart rate were normal. The 1st red cells unit was transfused in outpatient
hospitalisation from 12:00 p.m. to 2:30 p.m. The transfusion of the 2nd red cells unit began at 2:40 p.m. in outpatient hospitalisation and continued in conventional
hospitalisation (in Hepatology care unit) from 3:45 p.m. At 3:42 p.m., the patient had an arterial pressure of 150/73 mmHg, and heart rate of 61 beats/min. At the end of the
transfusion (5:15 p.m.), blood pressure and heart rate were normal. At 5:30 p.m., the patient was in acute respiratory distress with massive acute pulmonary oedema
(disorders of consciousness, 36% desaturation in ambient air). Rapidly unfavourable evolution, no resuscitation advice given the unfavourable short-term prognosis. The
patient died at 5:45 p.m.
CASE 3
A 78-year-old patient with COVID-19 (O RhD positive blood type), was hospitalized in a moderately severe state, with dyspnoea at rest and multiple comorbidities, including
multiple organ failure. Saturation 80%. Oxygen therapy was in use since the patient’s admission to Emergency Room. Transfusion of convalescent plasma was planned and
there were no indications for administration of packed RBCs. As a result of human error however, the patient was given 1 unit of packed leukocyte depleted RBCs intended
for another patient (incompatible A RhD positive blood type). No symptoms of adverse reaction were observed during transfusion and immediately after the procedure was
terminated.
According to plan, the patient was then transfused with 1 unit of group-compliant convalescent plasma and no adverse reactions were reported. 2.5 hours after termination
of the second transfusion, the patient's condition deteriorated, and blood pressure dropped. Additional tests revealed: strong haemolysis in serum, anaemia, elevated levels
of bilirubin. After about 8 hs from the onset of the first symptoms, blood saturation dropped to 70% (intubation, ventilation), followed by cardiac arrest and death an hour
later. The patient was resuscitated, to no effect.
Acute haemolytic reaction was recognized due to transfusion of incompatible packed RBCs.
The hospital physicians and nurses discussed the circumstances of this serious adverse reaction and were instructed to strictly follow all transfusion procedures in order to
avoid future errors of the same kind.
31
Annex 2. Overview of the 2018 - 2022 SARE reporting exercises (2017 - 2021 data)
2018 2019 2020 2021 2022
(data 2017) (data 2018) (data 2019) (data 2020) (data 2021)
Parameter
Countries Countries Countries Countries Countries
Number Number Number Number Number
reporting reporting reporting reporting reporting
20 633 199
Units issued 29 25 093 906 28 22 922 191 27 22 863 118 30 22 104 136 25
17 808 869
Units transfused 24 20 674 603 23 19 310 224 22 19 334 629 24 18 881 223 26
Recipients 2 752 465
19 3 522 623 19 3 262 767 17 3 228 635 15 2 912 173 19
transfused
2 814
SAR (1-3) 28 3 114 27 2 538 27 2 625 28 2 967 27
SAR (2-3) 26 1 871 24 1 687 26 1 674 26 1 756 24 1 379
SAR death
8 28 7 20 10 26 9 24 11 25
(2-3)
2 734
SAE 20 2 920 23 2 770 22 2 604 24 3 018 24
SAR in donors 23 4 635 23 6 239 24 3 821 28 4 025 23 2 946
32
Annex 3: Annual comparison (Years of exercises 2013-2022): number of units issued/transfused/recipients
30,000,000
25,717,028 25,324,888
25,129,344 24,827,516 24,827,516
25,000,000 24,043,766
22,922,191 22,863,135
22,104,136
21,425,047 21,443,125
20,910,579 20,674,603 20,633,199
20,000,000 19,267,785 19,322,367 18,881,223
17,808,869
16,564,817
15,000,000
13,351,948
10,000,000
5,000,000 4,190,835 4,246,978
3,595,155 3,216,938 3,123,147 3,089,746 2,913,325 2,967,012 2,912,173 2,752,465
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
Units issued Units transfused Recipients transfused
33
Annex 4: Annual comparison (Years of exercises 2013-2022): SAR (1-3), SAR (2-3), SAE, SAR in donors
9,000
8,000
7,769 7,658
7,000
6,239
6,000
5,000
4,460 4,635
4025
4,000
3,519
3,723 3,821
3,114
2,831 2,950 2967
2,814
3,000 2,953 2,972 2,587 2,920 2,625 3018 2,946
2,441 2,770 2,734
2,494 2,470 2,599 2604
2,338 2512
1,831 1,739 1,737 1,871 1756
2,000 1,636 1,674
1,410 1,349 1,379
1,000
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
SAR (1-3) SAR ( 2-3) SAE SAR in donors
34
Annex 5: Annual comparison (Years of exercises 2013-2022): number of deaths (2-3)
30
28
27
26
25 25
25 24
22 22
20
20
16
15
10
5
0
2013 2014 2015 2016 2017 2018 2019 2020 2021 2022
35
Saatja: <
[email protected]>
Saadetud: 09.10.2023 18:40
Adressaat: <
[email protected]>; EDQM SARE-BLOOD <SARE-
[email protected]>
Koopia: AMBROSIO Massimo <
[email protected]>; FEHILY Deirdre
<
[email protected]>; VAN DER SPIEGEL Stefaan <Stefaan.VAN-DER-
[email protected]>
Teema: Final report SARE blood 2022 (data 2021)
Dear competent authorities for blood and blood components,
Please find attached the final report of the SARE exercise on blood 2022
(data 2021).
As you have thoroughly reviewed the preliminary analysis, you should not
expect mayor changes in this file. We would appreciate if you could take
a final look and provide us your comments (if any) until 23rd October
2023.
Please do not hesitate to contact us or directly EDQM (in copy) for any
question or doubt.
Many thanks and kind regards,
The SoHO team.
European Commission DG SANTE (Health and Food Safety)
Unit D2 Medical Products: quality, safety, innovationOffice address: Rue
Breydel 2, 06/004, B-1049 Brussels/Belgium