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Trend in ABO‐incompatible RBC transfusion‐related fatalities reported to the FDA , 2000‐2019
Author(s) -
Storch Emily K.,
Rogerson Beth,
Eder Anne F.
Publication year - 2020
Publication title -
transfusion
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.045
H-Index - 132
eISSN - 1537-2995
pISSN - 0041-1132
DOI - 10.1111/trf.16121
Subject(s) - abo blood group system , medicine , food and drug administration , demographics , abo incompatibility , blood transfusion , emergency medicine , pediatrics , surgery , demography , medical emergency , sociology
Background ABO‐incompatible red blood cell (RBC) transfusions and acute hemolytic reactions occur infrequently, yet resultant fatalities are reported to the US Food and Drug Administration (FDA) every year. We describe a 20‐year retrospective study of reported mistransfusion cases to identify temporal trends, common causes, and corrective actions taken to prevent recurrence. Study Design and Methods ABO‐incompatible RBC transfusion‐related fatalities reported to the FDA in 2000‐2019 were reviewed for patient demographics, primary attributed cause, contributing factors, and corrective actions. Results Eighty reported deaths after ABO‐incompatible RBC transfusion occurred in the 20‐year period. A decrease in the number of cases after 2008 was sustained through 2019 (mean 6 cases/y, 2000‐2009 vs 2 cases/y, 2010‐2019). The estimated rate of reported mistransfusion fatalities was 1 per 2 million RBC units transfused in 2000‐2009 and 1 per 7.14 million RBC units in 2010‐2019 ( P < .0001). Administration errors (wrong patient or wrong unit transfused) and sample collection errors (wrong blood in tube [WBIT]) significantly decreased over time but remained the most common causes. In all WBIT cases, verification of patients' ABO type with a second sample or historical type was not performed before transfusion; 16 of 19 (84%) institutions that reported corrective actions subsequently instituted this requirement. In the other categories, 22 of 58 (38%) facilities reported plans for technological process improvements, such as electronic patient identification. Conclusions The rate of reported fatalities from ABO‐incompatible RBC transfusion has significantly decreased in the past decade. Still, about two cases are reported each year, highlighting gaps in best practices and areas for improvement.