Description of Event or Problem · 1
MEDICAL RECORD REVIEW DEMONSTRATES THE FOLLOWING: PATIENT IS A (B)(6) FEMALE WITH A HISTORY OF LEFT BREAST CANCER (B)(6), TREATED WITH LUMPECTOMY AND RADIATION. SHE SUBSEQUENTLY DEVELOPED RIGHT BREAST CANCER AND ON (B)(6) 2011, UNDERWENT BILATERAL MASTECTOMY WITH IMMEDIATE RECONSTRUCTION WITH TISSUE EXPANDERS AND ALLODERM (LEFT BREAST ONLY). ON (B)(6) 2011, THE PATIENT PRESENTED TO THE HOSPITAL WITH FEVER, CHILLS AND RIGORS AFTER ONE COURSE OF ANTIBIOTICS AND RECENT CHEMOTHERAPY; SHE WAS ADMITTED FOR LEFT BREAST CELLULITIS WITH SUSPECTED LEFT BREAST ABSCESS. THE MEDICAL RECORDS NOTE THAT THE DIFFICULTY WITH THE LEFT BREAST TISSUE EXPANDER WAS LIKELY DUE TO PRIOR RADIATION. ON (B)(6) 2011, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF INFECTED LEFT BREAST TISSUE EXPANDER, DEBRIDEMENT OF LEFT BREAST, AND REMOVAL OF ALLODERM. PUS WAS FOUND AROUND THE TISSUE EXPANDER. BLOOD CULTURES PERFORMED AT THE TIME OF ADMISSION WERE NEGATIVE. LEFT BREAST WOUND CULTURES COLLECTED ON POD #2 ((B)(6) 2011), WERE POSITIVE FOR (B)(6). THE PATIENT DEVELOPED NEUTROPENIA POSTOPERATIVELY, WHICH RESOLVED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND INFECTION RESOLVED. ALLODERM RTU IS A TERMINALLY STERILIZED PRODUCT; THEREFORE, FINAL PROCESSING CULTURES ARE NOT PERFORMED. REVIEW OF ENVIRONMENTAL MONITORING (EM) RECORDS REVEALED THAT AREAS RELEVANT TO THE PRODUCTION OF LOT B40950R WERE WITHIN A STATE OF CONTROL DURING A WEEK BEFORE, DURING, AND A WEEK AFTER PROCESSING OF THE LOT. NO EM EXCURSION OR UNEXPECTED EVENTS WERE ENCOUNTERED IN THE RELEVANT PROCESSING AREAS THAT COULD AFFECT PRODUCT QUALITY. THE TISSUE RECOVERY PARTNER HAS BEEN NOTIFIED OF THE COMPLAINT AND HAS REPORTED TO LIFECELL THAT THERE WERE NO OTHER COMPLAINTS OR ISSUES CONCERNING TISSUE/GRAFTS. MEDICAL RECORDS ARE ATTACHED. BASED ON LIFECELL'S INTERNAL INVESTIGATION, AND THE PHYSICIAN OPINION THAT PROBLEMS WITH THE TISSUE EXPANDER WERE RELATED TO IRRADIATION TO THE AREA, AND THE FACT THAT THE PATIENT WAS UNDERGOING CHEMOTHERAPY AT THE TIME OF THE EVENT, LIFECELL CONCLUDES THIS EVENT IS HIGHLY UNLIKELY RELATED TO THE ALLODERM RTU GRAFT. LIFECELL RECEIVED AN EXPLANT RECORD BY MAIL FROM (B)(4) WITH MINIMAL INFORMATION. LIFECELL PLACED A FOLLOW UP CALLED INTO THE PHYSICIAN'S OFFICE WHERE AN INFECTION WAS CONFIRMED. ADDITIONAL INFORMATION CONCERNING THE NATURE OF EVENT AND PATIENTS CONDITION AND TREATMENT HAS BEEN REQUESTED WITH NO FURTHER REPLY TO DATE. OUR INVESTIGATION INTO THE COMPLAINT RELATED LOT B40950R INCLUDES THE FOLLOWING: REVIEW OF THE DONOR RECORDS, WITH NO REMARKABLE FINDINGS. REVIEW OF MICROBIOLOGICAL TEST RESULTS FOR THE INCOMING SKIN REVEALED NO GROWTH IN THE CULTURE. FINAL MICROBIOLOGICAL CULTURES ARE NOT PERFORMED AS ALLODERM RTU IS A TERMINALLY STERILIZED PRODUCT. REVIEW OF THE PROCESSING RECORDS RESULTED IN NO REMARKABLE FINDINGS; THERE WERE NO DEVIATIONS RELATED TO THE NATURE OF THIS COMPLAINT. TO DATE, OF THE (B)(4) GRAFTS PROCESSED FOR LOT B40950R, (B)(4) GRAFTS WERE DISTRIBUTED WITH (B)(4) GRAFTS THAT WERE REPORTED TO BE IMPLANTED AND (B)(4) OTHER COMPLAINT (SEROMA) REPORTED TO LIFECELL AGAINST THIS LOT. A QUERY TO THE TISSUE RECOVERY PARTNER FOR REPORTS OF ANY ADVERSE REACTIONS ASSOCIATED WITH THE DONOR TISSUE HAS BEEN INITIATED WITH NO RESPONSE TO DATE. BASED ON THE INTERNAL INVESTIGATION INTO COMPLAINT RELATED LOT, INCLUDING MICROBIOLOGICAL TEST RESULTS, TERMINAL STERILIZATION PROCESS, AND THAT NO OTHER COMPLAINTS WERE REPORTED AGAINST GRAFTS DISTRIBUTED FROM THIS LOT, THE EVENT IS UNLIKELY RELATED TO THE ALLODERM RTU. LIFECELL IS CONSERVATIVELY REPORTING THIS EVENT DUE TO THE LACK OF INFORMATION ASSOCIATED WITH A REPORT OF INFECTION ASSOCIATED WITH THE USE OF ALLODERM RTU.