Adverse Occurrence type:
Alerting signals, symptoms, evidence of occurrence:
Between March 1, 2004, and May 31, 2006, bacterial culture testing was performed on 1,004,206 donations; of these, 186 (1:5,399) had confirmed-positive culture results. Transfusion of all but 1 of the associated 293 components was prevented. During this period, 20 septic transfusion reactions were reported, including 3 fatalities (1:498,711 fatalities per distributed component), which implicated screened-negative apheresis PLT products. Bacterial cultures and sensitivity were carried out on both patients and platelet components.
Demonstration of imputability or root cause:
Septic transfusion reaction was defined by clinical criteria associated with a culture-positive residual component and a culture-positive recipient demonstrating the same bacteria as determined by antibiotic sensitivity and/or pulsed-field gel electrophoresis or by clinical criteria in both recipients of proven culture-positive cocomponents.
Eder, A.F., Kennedy, J.M., Dy, B.A., Notari, E.P., Weiss, J.W., Fang, C.T., Wagner, S., Dodd, R.Y., Benjamin, R.J., and ARC Regional Blood Centers (2007). Bacterial screening of apheresis platelets and the residual risk of septic transfusion reactions: the American Red Cross experience (2004-2006).Transfusion 47(7):1134-42.