FDA Releases 2021 Report on Fatalities Following Blood Collection and Transfusion

September 29, 2023

The Food and Drug Administration recently published a new report that summarizes fatalities possibly linked to blood collection and transfusion in the United States for fiscal year (FY) 2021. The report sheds light on incidents reported between Oct. 1, 2020, and Sept. 30, 2021, and offers insights by comparing this data to those from the previous five fiscal years.

During FY 2021, the FDA received 91 reports of fatalities. Of these, 60 were potentially connected to transfusions, while 31 were potentially related to donations. Among transfusion-related fatalities, 42 (70%) were categorized as definite, probable or possible; ten (17%) were doubtful or indeterminate; and eight (13%) were excluded from the analysis. Regarding donation-related deaths, seven (23%) were classified as probable or possible; 17 (54%) were doubtful or indeterminate; and seven (23%) were excluded.

In FY 2021, the leading cause of transfusion-related fatalities was transfusion-associated circulatory overload (TACO), accounting for 36% of reported cases, including five definite and 10 probable or possible instances. Transfusion-related acute lung injury (TRALI) and possible TRALI cases (combined) followed as the second leading cause at 16%, with seven definite, probable or possible cases.

Between 2017 and 2021, TACO remained the most common cause of fatalities (32%), followed by TRALI and possible TRALI combined (21%), hemolytic transfusion reactions (HTRs) due to non-ABO incompatibilities (14%), microbial contamination (13%), anaphylaxis reactions (9%), HTRs due to ABO incompatibilities (7%), cases where the transfusion reaction type was not determined (3%) and other rare causes (1%). Prior to 2017, TRALI was consistently the leading cause of transfusion-associated fatalities, but the report highlights a decline in TRALI-related deaths due to voluntary measures implemented by the transfusion community to mitigate TRALI risk.

In FY2021, there were five cases of contamination-related fatalities, all attributed to apheresis platelets contaminated with bacteria. Two of the cases were co-components from the same collection. Cultures from the implicated units grew Escherichia coli, Staphylococcus aureus, S. saprophyticus, Corynebacterium, Bacillus (not anthracis), Acinetobacter baumannii complex, and Leclercia adecarboxylata.

The agency concluded that overall, the number of transfusion-associated fatalities reported remains small, but relatively constant, in comparison to the total number of transfusions. FDA encouraged readers to interpret the reported changes cautiously, given the small numbers of reports and inherent variations in reporting accuracy.