December 06, 2021
The Food and Drug Administration updated its April 2019 safety communication related to bacterial contamination of platelets for transfusion to notify blood establishments and transfusion services of additional cases of septic transfusion reactions from apheresis platelets contaminated with Acinetobacter species and certain other bacterial species in combination. The most recently reported cases have involved pathogen-reduced platelet components.
Since the 2019 communication, FDA has learned of three additional septic transfusion reactions involving either Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecaboxylata or combinations thereof. The cases occurred in North Carolina, Virginia and Ohio, but genetic testing of the isolates by the Centers for Disease Control and Prevention (CDC) “found with high probability that the organisms are related.”
The contaminated components, prepared in platelet additive solution and further processed with a pathogen-reduction device, resulted in two cases of fatal septic transfusion reactions. FDA and CDC are investigating additional reports of potential septic transfusion reactions and positive bacterial cultures with Acinetobacter species and certain other bacterial species.
Since 2018, a total of seven cases of platelet septic transfusion reactions associated with Acinetobacter species and certain other bacterial species in combination have been reported to FDA. Additional genetic testing conducted by CDC indicates the relatedness of the organisms that “may have a common source; however, no such source has been identified to date.” The FDA and CDC investigations are continuing.
In light of these rare cases, FDA reminds blood establishments and transfusion services of the importance of recognizing the residual risk of bacterial contamination of platelets, including pathogen-reduced components. Suspected reactions should be reported immediately to the transfusion service and blood supplier and be thoroughly investigated as appropriate. As described in 21 CFR 606.170, facilities must notify FDA as soon as possible following the confirmation of a fatal transfusion complication.
To facilitate investigation, FDA encourages facilities to report suspected contamination of platelets with Acinetobacter spp., Staphylococcus saprophyticus or Leclercia adecarboxylata, or suspected septic transfusion reactions involving pathogen-reduced platelet components. Facilities may report cases via MedWatch or by emailing CBER.
Members with additional questions may contact regulatory@aabb.org.