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Patient 1
CERUS MEDICAL ASSESSMENT: CERUS MEDICAL REVIEWER CONCURS WITH THE REPORTER'S ASSESSMENT THAT THE EVENT WAS NON-SEVERE AND SERIOUS DUE TO HOSPITALIZATION/PROLONGATION OF HOSPITALIZATION. A DEVICE MALFUNCTION WAS NOT REPORTED. HOWEVER, THE CERUS MEDICAL REVIEWER DOES NOT CONCUR WITH THE REPORTER'S ASSESSMENT THAT THE EVENT CONSTITUTED A "SUSPECTED SEPTIC TRANSFUSION REACTION", OR THAT IS WAS PROBABLY RELATED TO THE TRANSFUSION OF INTERCEPT PLATELETS. NO EVIDENCE WAS PROVIDED THAT THE PLATELET CONCENTRATE WAS CONTAMINATED AND THE FEVER APPARENTLY DID NOT COINCIDE WITH THE TRANSFUSION. PATIENT SYMPTOMATOLOGY AND CLINICAL EVOLUTION DOES NOT SUPPORT THE PRESUMPTIVE DIAGNOSIS OF A SEPTIC TRANSFUSION REACTION. PLATELET COUNT INCREMENT POST TRANSFUSION DOES NOT SUPPORT IT EITHER, AND THE PLATELET BAGS WERE NOT CULTURED OR EXAMINED. INTERCEPT BLOOD TREATMENT RESULTS IN GREATER THAN OR EQUAL TO 6.3 LOG REDUCTION (CFU/ML) OF E. COLI PER THE APPROVED PACKAGE INSERT. NUSSBAUMER ET AL. TESTED THE PATHOGEN INACTIVATION EFFICACY OF THE IBS WITH VARYING CONCENTRATIONS OF SEVEN BACTERIAL SPECIES (INCLUDING E.COLI 1-100 CFUS/UNIT) AND FOUND THAT NO BACTERIA WERE DETECTED THROUGHOUT 5 DAYS OF STORAGE REGARDLESS OF THE SPECIES, LEVEL OF CONTAMINATION, AND SAMPLING TIME. CONVERSELY, OTHER SOURCES OF INFECTION, SUCH AS A URINARY TRACT INFECTION WERE NOT RULED OUT. LACKING EVIDENCE OF PLATELET CONTAMINATION, BACTERIAL ISOLATES OR FURTHER CLINICAL EVIDENCE TO SUPPORT A DIAGNOSIS OR A SUSPECTED SEPTIC TRANSFUSION REACTION, IT IS CONCLUDED THAT THE EVENT WAS UNLIKELY RELATED TO THE INTERCEPT BLOOD SYSTEM OR THE PLATELET TRANSFUSION. NUSSBAUMER W, ALLERSTORFER D, ET AL. PREVENTION OF TRANSFUSION OF PLATELET COMPONENTS CONTAMINATED WITH LOW LEVELS OF BACTERIA: A COMPARISON OF BACTERIA CULTURE AND PATHOGEN INACTIVATION METHODS. TRANSFUSION 2007 JUL;47(7):1125-33. NOT RETURNED TO MANUFACTURER.