FDA Adverse Event Summary report: N

EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT

MDR report key: 1220604 · Received November 3, 2008

Report

Report Number
1226230-2008-00015
Date Received
November 3, 2008
Report Date
October 6, 2008
Manufacturer
GENZYME BIOSURGERY (CAMBRIDGE)
Product Code
MGR
PMA / PMN Number
HDE 990002
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
GA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

THERMAL BURNS [THERMAL BURN]. DISSEMINATED INTRAVASCULAR COAGULATION [DISSEMINATED INTRAVASCULAR COAGULATION]. RESPIRATORY FAILURE [RESPIRATORY FAILURE]. CARDIAC ARREST [CARDIAC ARREST]. PLEURAL EFFUSIONS [PLEURAL EFFUSION]. ELECTROLYTE ABNORMALITIES [ELECTROLYTE IMBALANCE]. GNR INFECTION [BACTERIAL INFECTION]. M. MORGANII INFECTION [MORGANELLA INFECTION]. S. MARCESCE INFECTION [SERRATIA INFECTION]. P. AERUGINO INFECTION [PSEUDOMONAS INFECTION]. E. GALLINAR INFECTION [ENTEROCOCCAL INFECTION]. A. BAUM/HAE [ACINETOBACTER INFECTION]. C. ALBICANS INFECTION [CANDIDIASIS]. THROMBOCYTOPENIA [THROMBOCYTOPENIA]. DEATH [DEATH]. GRAM NEGATIVE SEPSIS (SEPSIS). HYPERTENSION [HYPERTENSION]. A. XYLO XYL [INFECTION]. SPONTANEOUS REPORT RECEIVED ON 06-OCT-2008 FROM AN OTHER HEALTH PROFESSIONAL (NURSE) REGARDING A (B)(6) MALE PT, (B)(6), WHOSE RELEVANT MEDICAL HISTORY INCLUDED: AN EXPLOSION INJURY, THERMAL BURNS, A SKIN BIOPSY, TOPICAL ANTIMICROBIAL OR ANTIFUNGAL MEDICATIONS, SYSTEMIC ANTIMICROBIAL OR ANTIFUNGAL MEDICATIONS, MULTIPLE SURGICAL EXCISIONS OR BURN WOUNDS, MULTIPLE ALLOGRAFTS, MULTIPLE XENOGRAFTS, INTUBATION, VERSED DRIP TREATMENT, ESCHAROTOMY OF THE LEFT ARM, A. BAUM (ACINETOBACTER BAUMANNII) INFECTION, BIPOLAR SP. INFECTION, C. ALBICANS (CANDIDA ALBICANS) INFECTION, ENTEROVIRUS INFECTION, (B)(6) INFECTION, MOLD INFECTION, (B)(6) INFECTION, S. MALTOPH (STENOTROPHOMONAS MALTOPHILIA), AND YEAST INFECTIONS. ON (B)(6)-2008, THE PT SUSTAINED A BURN SECONDARY TO A PROPANE TANK EXPLOSION. HE WAS ADMITTED TO THE HOSP ON (B)(6)-2008, WHERE HE WAS INTUBATED AND PLACED ON A VERSED DRIP. HE WAS THEN TRANSFERRED TO THE BURN UNIT OF A DIFFERENT HOSPITAL, WHERE HE WAS ON MECHANICAL VENTILATION AND NOTED TO HAVE SUSTAINED A 62 % TOTAL BODY SURFACE AREA (TBSA) BURN. THE PT WAS BROUGHT TO THE OPERATING ROOM ON MULTIPLE OCCASIONS FOR INITIAL EXCISION AND TEMPORARY COVERAGE. HIS WOUNDS PROGRESSED NICELY AND EPICEL CEA (CULTURED EPIDERMAL AUTOGRAFTS) WERE APPLIED ON (B)(6)-2008. HOWEVER, THE PT'S OVERALL CONDITION CONTINUED TO DETERIORATE AND HIS HOSPITALIZATION WAS COMPLICATED BY: ELECTROLYTE ABNORMALITIES, SEPSIS, DIC (DISSEMINATED INTRAVASCULAR COAGULATION), AND HYPERTENSION. THE PT RECEIVED ANTIBIOTICS AS TREATMENT FOR SEPSIS AND BLOOD PRODUCTS AS TREATMENT FOR DIC. HE WAS MEDICALLY MANAGED BY ACCA AND REMAINED ON MECHANICAL VENTILATION FOR RESPIRATORY FAILURE. HE ALSO EXPERIENCED ISSUES WITH PLEURAL EFFUSIONS. A CHEST TUBE WAS PLACED AND CONTINUOUS DIALYSIS WAS ADMINISTERED FOR FLUID REMOVAL. THE FAMILY WAS AWARE OF THE PT'S CRITICAL CONDITION AND MADE HIM A CHEMICAL CODE ONLY. ULTIMATELY, THE PT'S TREATMENTS WERE PUT ON HOLD AND HE EXPIRED ON (B)(6)-2008, PRIMARILY SECONDARY TO GRAM-NEGATIVE SEPTICEMIA. PRIOR TO DEATH, THE PT'S TOTAL BILIRUBIN WAS 47.9 WITH A LACTIC ACID OF 10. THE DISCHARGE SUMMARY DIAGNOSES WERE: 62% TBSA BURN (FULL-THICKNESS), RESPIRATORY FAILURE (SEVERE), GRAM-NEGATIVE SEPSIS (SEVERE), DISSEMINATED INTRAVASCULAR COAGULATION (SEVERE), CARDIAC ARREST, ELECTROLYTE ABNORMALITIES, AND THROMBOCYTOPENIA. LAB RESULTS INDICATED THAT THE PT EXPERIENCED THE FOLLOWING INFECTIONS AFTER HIS EPICEL TREATMENT: A. BAUM ((B)(6)-2008), C. ALBICANS ((B)(6)-2008), ((B)(6): (B)(6)-2008), A. XYLO. XYL. ((B)(6)-2008), S. MARSCE (SERRATIA MARSCECENS ((B)(6)-2008), P. AERUGINO (PSEUDOMONAS AERUGINOSA: (B)(6)-2008), M. MORGANNI (MORGANELLA MORGANII: (B)(6)2008), GNR (GRAM-NEGATIVE ROD: (B)(6)-2008), AS OF THE DATE OF THE RECEIPT OF THIS REPORT, THE PT'S OUTCOME WAS FATAL ON (B)(6)-2008. AN AUTOPSY WAS NOT PERFORMED. THE OTHER HEALTH PROFESSIONAL (NURSE) ASSESSED THE RELATIONSHIP BETWEEN THE EVENTS "RESPIRATORY FAILURE", "SEPSIS", AND "DIC" AND EPICEL AS NOT RELATED. THE PT'S SKIN BIOPSY REPORT WAS OBTAINED ON 07-OCT-2008. THE DATE OF THE BIOPSY WAS (B)(6)-2008 AT 10:11 HOURS. THE BIOPSY SITE OF TUBE #1 WAS THE RIGHT GROIN AND THE BIOPSY SITE OF TUBE #2 WAS THE LEFT GROIN. THE EXPIRATION DATE ON THE TUBES WAS 30-OCT-2008. THE EPICEL LOT # WAS EE01188. CURRENT TOPICAL ANTIMICROBIAL OR ANTIFUNGAL MEDICATIONS INCLUDED: 4 MEDICATIONS (NAMES NOT PROVIDED). CURRENT SYSTEMIC ANTIMICROBIAL OR ANTIFUNGAL MEDICATIONS INCLUDED 1 MEDICATION (NAME NOT PROVIDED). AT THE TIME OF THE BIOPSY, THE PT HAD A SYSTEMIC MICROBIAL INFECTION (ORGANISM NOT SPECIFIED). THE STERILITY RESULTS WERE RECEIVED ON 09-OCT-2008. ALL STERILITY RESULTS WERE RECEIVED ON 09-OCT-2008. ALL STERILITY AND ENVIRONMENTAL MONITORING FOR THE PRODUCTION OF EPICEL LOT # EE01188 MET ACCEPTANCE CRITERIA.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 EPICEL (CULTURED EPIDERMAL AUTOGRAFTS) GRAFT CULTURED EPIDERMAL AUTOGRAFTS MGR GENZYME BIOSURGERY (CAMBRIDGE) UNK EE01188

Patients

Seq Age Sex Outcome Treatment
1 69 YR Death| H| O| R