FDA is updating the communication first issued on April 16, 20191, to inform blood establishments and transfusion services of additional cases of septic transfusion reactions from apheresis platelets contaminated with Acinetobacter species and certain other bacterial species seen in combination. Until these cases were reported, Acinetobacter spp. had been only rarely identified as contaminants in apheresis platelet components.
FDA and the Centers for Disease Control and Prevention (CDC) continue to investigate these reports, including those described in recent publications2-5. Notably, recent cases have involved pathogen reduced platelet components.
Summary of the Issue
Since the 2019 safety communication, FDA is aware of three additional septic transfusion reactions involving either Acinetobacter spp., Staphylococcus saprophyticus, Leclercia adecaboxylata, or combinations thereof. Additional genetic testing of isolates by the CDC found with high probability that the organisms are related. These cases occurred in North Carolina, Virginia, and Ohio. The implicated components were prepared in platelet additive solution and further processed with a pathogen reduction device. Two of these cases resulted in fatal septic transfusion reactions. Additional reports of potential septic transfusion reactions and positive bacterial cultures with Acinetobacter species and certain other bacterial species are under investigation.
Altogether, since 2018, 7 cases of platelet septic transfusion reactions have been reported to FDA associated with Acinetobacter species and certain other bacterial species seen in combination, and where additional genetic testing indicates relatedness of the organisms.
Based on the genetic testing conducted by the CDC, these organisms may have a common source; however, no such source has been identified to date. FDA and the CDC will continue their investigation
Recommendations to Blood Establishments and Transfusion Services
These unusual cases demonstrate that it is important for blood establishments and transfusion services to recognize the residual risk of bacterial contamination of platelets, including pathogen-reduced platelet components. Signs and symptoms of potential septic transfusion reactions include fever, chills, hypotension, or unexplained tachycardia. Suspected reactions should be immediately reported to the transfusion service and blood supplier. Blood establishments and transfusion services, as appropriate, must conduct and record a thorough investigation of suspected septic transfusion reactions and notify FDA as soon as possible when a complication of transfusion is confirmed to be fatal (21 CFR 606.170).
To facilitate further investigation, we encourage blood establishments and transfusion services to contact FDA when they identify suspected contamination of platelets with Acinetobacter spp., Staphylococcus saprophyticus, or Leclercia adecarboxylata, or suspected septic transfusion reactions involving pathogen-reduced platelet components, and report the cases via MedWatch (https://www.fda.gov/Safety/MedWatch/default.htm) or by emailing CBER at CBEROBRRBPBInquiries@fda.hhs.gov.
- U.S. Food and Drug Administration. Important Information for Blood Establishments and Transfusion Services Regarding Acinetobacter sp. Contamination of Platelets for Transfusion. 2019. Available: https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-blood-establishments-and-transfusion-services-regarding-acinetobacter-sp
- Nevala-Plagemann C, Powers P, Mir-Kasimov M, Rose R. A Fatal Case of Septic Shock Secondary to Acinetobacter Bacteremia Acquired from a Platelet Transfusion. Case Rep Med 2019; 2019: 3136493.
- Jones SA, Jones JM, Leung V, et al. Sepsis Attributed to Bacterial Contamination of Platelets Associated with a Potential Common Source - Multiple States, 2018. MMWR Morb Mortal Wkly Rep 2019; 68(23): 519-23.
- Fridey JL, Stramer SL, Nambiar A, et al. Sepsis from an apheresis platelet contaminated with Acinetobacter calcoaceticus/baumannii complex bacteria and Staphylococcus saprophyticus after pathogen reduction. Transfusion 2020; 60(9): 1960-9.
- Fadeyi EA, Wagner SJ, Goldberg C, et al. Fatal sepsis associated with a storage container leak permitting platelet contamination with environmental bacteria after pathogen reduction. Transfusion 2021; 61(2): 641-8.