THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(4) 2014 FROM A NURSE. THIS CASE INVOLVES A PATIENT (DEMOGRAPHICS NOT PROVIDED) WHO PASSED AWAY FOLLOWING FOUR TIMES GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO RELEVANT MEDICAL HISTORY, PAST DRUGS, CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2012, THE PATIENT WAS GRAFTED WITH FIFTEEN EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDICA FOR GRAFT WAS UNKNOWN) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2012, THE PATIENT WAS AGAIN GRAFTED WITH TWENTY THREE EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE0612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDICA FOR GRAFT WAS UNKNOWN). ON (B)(6) 2013, THE PATIENT WAS AGAIN GRAFTED WITH SIXTEEN EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT FOR GRAFT WAS UNKNOWN). ON (B)(6) 2013, THE PATIENT WAS LAST GRAFTED WITH SEVENTEEN EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDIA FOR GRAFT WAS UNKNOWN). ON (B)(6) 2014, THE PATIENT EXPIRED (CAUSE UNSPECIFIED). AUTOPSY: UNKNOWN. CORRECTIVE TREATMENT: NOT REPORTED. A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED AND THE RESULTS WERE PENDING FOR THE SAME.
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THIS UNSOLICITED CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2014 FROM A NURSE. BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014, THE EVENT OF SERRATIA MARCESCENS INFECTION WAS ADDED. BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2014, EVENTS OF RESPIRATORY FAILURE, BACTERIAL SEPSIS, "THE PATIENT REMAINED WITH OPEN WOUNDS EVENT AFTER THE USE OF EPICEL", "INCREASINGLY DEBILITATED" AND OFF LABEL USE WERE ADDED. THIS CASE INVOLVES A (B)(6) YEAR OLD FEMALE PATIENT WHO EXPERIENCED SERRATIA MARCESCENS INFECTION, RESPIRATORY FAILURE, BACTERIAL SEPSIS/BACTEREMIA, AND "THE PATIENT REMAINED WITH OPEN WOUNDS EVENT AFTER THE USE OF EPICEL", INCREASINGLY DEBILITATED FOLLOWING FOUR TIMES GRAFTING WITH EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL) FOR GOLTZ SYNDROME WITH CHRONIC OPEN WOUNDS (OFF LABEL USE). THE PATIENT HAD A MEDICAL HISTORY OF GOLTZ SYNDROME WITH CHRONIC OPEN WOUNDS. THE PATIENT HAD DRUG ALLERGY TO DOCUSATE SODIUM (COLACE) AND PENICILLIN (RASH). NO CONCOMITANT MEDICATIONS AND CONCURRENT CONDITIONS WERE REPORTED. ON (B)(6) 2012, THE PATIENT WAS GRAFTED WITH (B)(6) EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDIA FOR GRAFT WAS UNKNOWN) ON AN UNSPECIFIED LOCATION FOR THERMAL BURN. ON (B)(6) 2012, THE PATIENT WAS AGAIN GRAFTED WITH (B)(6) EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDIA FOR GRAFT WAS UNKNOWN). ON (B)(6) 2013, THE PATIENT WAS AGAIN GRAFTED WITH (B)(6) EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDIA FOR GRAFT WAS UNKNOWN). ON (B)(6) 2013, THE PATIENT WAS LAST GRAFTED WITH SEVENTEEN EPICEL CULTURED EPIDERMAL AUTOGRAFTS (BATCH/LOT NUMBER: EE01612; EXPIRATION DATE OF BIOPSY TRANSPLANT MEDIA FOR GRAFT WAS UNKNOWN). IT WAS REPORTED THAT THE SITUATION WAS VERY COMPLEX AS IT WAS AN OFF-LABEL USE OF EPICEL ON THE PATIENT. ON AN UNKNOWN DATE IN (B)(6) 2013, PATIENT HAD HER LAST USE WITH EPICEL WHICH WAS AT LEAST 9 MONTHS BEFORE THE DATE THE PATIENT PASSED AWAY. IT WAS REPORTED THAT THE PATIENT WAS SUFFERING FROM A VERY RARE INHERITED DISORDER AND BECAUSE OF THIS SYNDROME SHE HAD A LOT OF AREAS WITH OPEN WOUNDS THAT WOULD NOT HEAL SO THEY DECIDED TO TRY EPICEL ON THE PATIENT. THE PATIENT'S UNDERLYING DISEASE OF GOLTZ SYNDROME RESULTED IN INADEQUATE DERMIS AND CHRONIC OPEN WOUNDS. THE PATIENT WAS TREATED OVER A 2 YEAR PERIOD WHICH MULTIPLE TREATMENT MODALITIES INCLUDING EPICEL IN EFFECT TO CLOSE EXTENSIVE CHRONIC OPEN WOUNDS. REPORTEDLY, PATIENT WAS TAKING ANALGESICS. ALSO, THE PATIENT REMAINED WITH OPEN WOUNDS EVEN AFTER THE USE OF EPICEL AND THE PATIENT BECAME INCREASINGLY DEBILITATED FOR THE LAST SEVERAL MONTHS OF HER LIFE. REPORTEDLY, THE PATIENT DEVELOPED BACTERAEMIA MOST LIKELY DUE TO LONGSTANDING OPEN WOUND OR INVOLVED CENTRAL VENOUS CATHETER. THERE WAS LIMITED ENGRAFTMENT OF EPICEL DUE TO POOR QUALITY OF WOUND BEDS. ON AN UNKNOWN DATE, PATIENT DEVELOPED BACTERIAL SEPSIS FOR WHICH PATIENT WAS HOSPITALIZED. IT WAS REPORTED THAT THE PATIENT WAS ON INTRAVENOUS SEDATION AND WAS TREATED FOR SEPSIS (TREATMENT UNSPECIFIED AT THE TIME OF REPORT) BUT SHE HAD A RESPIRATORY FAILURE AND HER FAMILY DID NOT WANTED HER TO BE INTUBATED SO THEY WERE NOT ABLE TO TREAT HER. THE PATIENT'S CONDITION WORSENED DUE TO CHRONIC WOUNDS AND POOR NUTRITION. ALSO, REPORTED THERE WAS NO SPECIFIC CAUSAL RELATIONSHIP BETWEEN EPICEL. ON (B)(6) 2014, THE PATIENT EXPIRED (CAUSE UNSPECIFIED) DUE TO RESPIRATORY FAILURE. NO AUTOPSY WAS PERFORMED. THE STERILITY AND ENVIRONMENTAL MONITORING RESULTS WERE RECEIVED ON (B)(6) 2014. ALL STERILITY RESULTS FOR THE PRODUCTION OF EPICEL LOT EE01612 WERE NEGATIVE FOR CONTAMINATION. CORRECTIVE TREATMENT: ANTIBIOTICS FOR THE EVENTS OF BACTERIAL SEPSIS/BACTEREMIA, OPEN WOUNDS, S.MARCESCEN'S INFECTION OUTCOME: FATAL FOR RESPIRATORY FAILURE, UNKNOWN FOR BACTERIAL SEPSIS, SERRATIA MARCESCENS INFECTION, "THE PATIENT REMAINED WITH OPEN WOUNDS EVENT AFTER THE USE OF EPICEL" AND "INCREASINGLY DEBILITATED". IN THE REPORTER'S OPINION, GOLTZ SYNDROME WITH CHRONIC OPEN WOUNDS LEADING TO SEPSIS. A PRODUCT TECHNICAL COMPLAINT (PTC) WAS INITIATED WITH GLOBAL PTC NUMBER: (B)(4). QUALITY ASSURANCE PERFORMED A THOROUGH REVIEW OF THE LOT BATCH RECORDS AND NO ADDITIONAL FINDINGS WERE NOTED. ALL PROCESSES AND TESTING WERE PERFORMED ACCORDING TO STANDARD OPERATING PROCEDURES AND MET ALL RELEASE SPECIFICATIONS FOR THE ASSEMBLY DATES. QC REVIEWED THE FINAL PRODUCT RELEASE TESTING RECORDS AND CONFIRMED THAT ALL TESTING WAS COMPLETED AS EXPECTED AND NO ERRORS OCCURRED DURING TESTING. ALL STERILITY AND ENVIRONMENTAL MONITORING RESULTS WERE REVIEWED FOR ALL PRODUCTION AND ASSEMBLIES FOR LOT EE01612. THE RESULTS MET ACCEPTANCE CRITERIA AND WERE RELEASED BY QUALITY SYSTEMS. CONCLUSION/ROOT CAUSE/CAPA: THE REVIEW OF THE LOT BATCH RECORDS, SUPPORTING DOCUMENTATION, AND TESTING RESULTS INDICATE THAT THE LOT WAS MANUFACTURED ACCORDING TO STA...