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Patient 1
CERUS MEDICAL REVIEWER CONCURS WITH THE REPORTER'S ASSESSMENT THAT THE EVENT OF "SUSPECTED SEPTIC TRANSFUSION REACTION" WAS NON-SEVERE AND SERIOUS DUE TO HOSPITALIZATION/PROLONGATION OF HOSPITALIZATION A DEVICE MALFUNCTION WAS NOT REPORTED. IN CONSIDERING THE RELATEDNESS OF THIS EVENT TO THE PLATELET TRANSFUSION THE FOLLOWING FACTS SHOULD BE TAKEN INTO ACCOUNT: DUE TO THE UNDERLYING NATURE OF THE DISEASE (I.E. AML), AND THE CHEMOTHERAPY TREATMENT THE PATIENT WAS RECEIVING, IT IS REASONABLE TO ASSUME THAT THE PATIENT WAS IMMUNOCOMPROMISED. A CBC WAS NOT MADE AVAILABLE TO THE SPONSOR. THE PATIENT HAD NO EVIDENCE OF AN INFECTION PRIOR TO THE TRANSFUSION, BUT NO FORMAL BLOOD CULTURE WAS TAKEN PRIOR TO TRANSFUSIONS. A LINE CULTURE TAKEN BEFORE TRANSFUSION WAS CULTURED AND FOUND TO BE NEGATIVE. THE PATIENT EXPERIENCED CHILLS AND TACHYCARDIA. TEMPERATURE INCREASED FROM 37.4 DEGREES CELSIUS TO 37.8 DEGREES CELSIUS. CHILLS AND TACHYCARDIA ARE SUGGESTIVE OF A FEBRILE NON-HEMOLYTIC TRANSFUSION REACTION, ALTHOUGH THE TEMPERATURE EXCURSION DID NOT MEET THE DEFINITION OF A FEVER (RISE OF >1OC) AND THE PATIENT WAS NOT CLINICALLY SEPTIC. THE INTERCEPT BLOOD TREATMENT FOR PLATELETS IS HIGHLY EFFICACIOUS TO INACTIVATE S. AUREUS (GREATER THAN OR EQUAL TO 5.4 LOG REDUCTION (CFU/ML)). NO SPECIFIC PATHOGEN INACTIVATION STUDIES HAVE BEEN CONDUCTED WITH STAPHYLOCOCCUS HAEMOLYTICUS BUT GIVEN ITS SIMILARITIES WITH THE OTHER SPECIES, AND THE ABSENCE OF EVIDENCE OF STRAIN VARIABILITY IN SUSCEPTIBILITY TO PATHOGEN INACTIVATION, THE EFFICACY OF THE SYSTEM AGAINST THIS BACTERIA IS LIKELY COMPARABLE. CONTAMINATION AFTER PATHOGEN INACTIVATION TREATMENT WITH THE INTERCEPT BLOOD SYSTEM (IBS) BUT BEFORE TRANSFUSION CANNOT BE RULED OUT, BUT SEEMS UNLIKELY, GIVEN THE INTEGRITY OF THE CLOSED SYSTEM AND ROUTINE INSPECTION OF THE COMPONENT DURING HANDLING. GIVEN THESE CONSIDERATIONS, AN ALTERNATIVE EXPLANATION FOR THE EVENT THE CONTAMINATION OF THE PLATELET PRODUCT OCCURRED AFTER THE STERILE INTEGRITY OF THE COMPONENT WAS COMPROMISED BY "SPIKING" THE BAG FOR TRANSFUSION, AND CONTAMINATION OCCURRED BY RETROGRADE FLOW FROM A BACTEREMIA IN THE PATIENT. HOWEVER, LACKING FURTHER INFORMATION AND UNAVAILABILITY OF THE BACTERIAL ISOLATES FOR SENSITIVITY TESTING TO THE INTERCEPT PROCESS, FAILURE OF THE IBS TREATMENT TO COMPLETELY INACTIVATE THE BACTERIA IS POSSIBLE AND CANNOT BE RULED OUT AT THIS TIME. INCOMPLETE INACTIVATION OF BACTERIA WITH BREAKTHROUGH CONTAMINATION HAS BEEN REPORTED UNDER EXPERIMENTAL CONDITIONS WHERE THERE IS DELAY BETWEEN COLLECTION OF THE BLOOD PRODUCT AND THE PERFORMANCE IF THE INTERCEPT PROCESS. TREATMENT WITH INTERCEPT OCCURRED WITHIN 20 HOURS OF COLLECTION WHICH IS WITHIN SPECIFICATION, MAKING IT LESS LIKELY TO BE A FAILURE. WITH THE CURRENT INFORMATION, THE CERUS MEDICAL ASSESSMENT IS THAT THE PATIENTS TRANSFUSION REACTION IS "POSSIBLY RELATED" TO THE TRANSFUSION OF CONTAMINATED PLATELETS THAT HAD BEEN TREATED WITH THE INTERCEPT PROCESS AND FAILURE OF THE INTERCEPT PROCESS TO COMPLETELY INACTIVATE THE CONTAMINATION BACTERIA HAS NOT BEEN RULED OUT. DEVICE NOT RETURNED TO MANUFACTURER.