Important Information for Blood Establishments and Transfusion Services Regarding Acinetobacter sp. Contamination of Platelets for Transfusion

April 16, 2019

The Food and Drug Administration (FDA) is informing blood establishments of recent reports of platelet contamination with Acinetobacter species bacteria.  Bacterial contamination of platelets with this organism has caused septic transfusion reactions. Until the recent cases, Acinetobacter sp. had not been frequently identified as a contaminant in platelets.

Summary of the Issue

From April 2018 to the present, FDA has been informed of four collections of apheresis platelets in which contamination by Acinetobacter sp. was identified. The collections occurred in multiple regions of the country.  In three of the apheresis platelet collections, six total platelet components were produced. Four of these components caused septic transfusion reactions, including one fatality, while two components were not transfused. These septic transfusion reactions occurred despite the use of various bacterial mitigation measures. The fourth collection was identified as contaminated by bacterial testing; it was discarded and not transfused.   

FDA and the Centers for Disease Control and Prevention are investigating these reports.

Recommendations to Blood Establishments and Transfusion Services

To facilitate the investigations, we encourage blood establishments and transfusion services to contact FDA concerning cases of Acinetobacter sp. contamination of platelet products, which can be reported via MedWatch (https://www.fda.gov/Safety/MedWatch/default.htm) or your establishment’s corresponding Consumer Safety Officer, or by contacting CBER at industry.biologics@fda.hhs.gov.