EXPIRED [DEATH]. CASE DESCRIPTION: THIS SPONTANEOUS DEVICE CASE FROM UNITED STATES WAS RECEIVED ON (B)(6) 2015 FROM A HEALTHCARE PROFESSIONAL. THIS CASE CONCERNS A (B)(6) MALE PT WHO EXPIRED AFTER GRAFTING WITH 48 SHEETS OF EPICEL CULTURED EPIDERMAL AUTOGRAFTS (EPICEL). NO MEDICAL HISTORY, PAST DRUGS, CONCURRENT CONDITIONS, CONCOMITANT MEDICATION WERE REPORTED. THE PT HAD RECEIVED THE GRAFT FOLLOWING THERMAL BURNS TO 76% OF THE BODY SURFACE AREA. THE SKIN BIOPSY OF THE PT HAS BEEN TAKEN ON (B)(6) 2015. ON (B)(6) 2015, THE PT WAS GRAFTED WITH 48 SHEETS OF EPICEL GRAFTS BATCH/LOT NUMBER EE01947A. ON (B)(6) 2015, THE PT EXPIRED. FURTHER DETAILS INCLUDING DESCRIPTION OF CLINICAL PRESENTATION, SIGNS, SYMPTOMS, BASELINE DATA, DIAGNOSIS, CAUSE OF DEATH AND AUTOPSY RESULTS WERE NOT REPORTED. OUTCOME: FATAL. SERIOUSNESS CRITERION: DEATH. THE REPORTER DID NOT PROVIDE THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND EPICEL GRAFTS. HOWEVER, AS PER THE CONDITIONS OF THE HUMANITARIAN DEVICE EXEMPTION, THAT "UNLESS DEATH IS SPECIFICALLY REPORTED AS "NOT RELATED" TO EPICEL BY THE REPORTER, IT WILL BE CONSIDERED CAUSALLY RELATE", THIS EVENT IS CONSIDERED AS RELATED TO EPICEL GRAFTS. SEE SCANNED PAGE.
N
Patient 1
FOLLOW-UP INFORMATION WAS RECEIVED ON NOVEMBER 12, 2015 FROM A HEALTH CARE PROFESSIONAL. THE PATIENT'S RACE AND ETHNICITY WERE REPORTED AS WHITE AND NON-HISPANIC. THE PATIENT'S MEDICAL HISTORY INCLUDED ALLERGY TO CODEINE. ADDITIONAL DETAILS REGARDING CONCOMITANT MEDICATIONS WERE NOT AVAILABLE DUE TO PATIENT'S CRITICAL CONDITION. ON (B)(6) 2015, AT WORK THE PATIENT HAD 76 PERCENT DEEP PARTIAL AND MAJORITY OF FULL THICKNESS BURNS SECONDARY TO GAS LINE EXPLOSION. THE CO-WORKERS CALLED THE EMERGENCY MEDICAL SERVICE IMMEDIATELY. AT 14.35, UPON ARRIVAL OF EMERGENCY MEDICAL SERVICE THE PATIENT COMPLAINED OF DIFFICULTY IN BREATHING. UPON EXAMINATION, IT WAS NOTED THAT THE PATIENT SUFFERED 54 PERCENT THIRD DEGREE THERMAL BURNS ON ENTIRE HEAD (POSTERIOR AND ANTERIOR), NECK (ENTIRE ANTERIOR AND POSTERIOR CIRCUMFERENCE) CHEST, BACK, BUTTOCKS AND BILATERAL ARMS AND 18 PERCENT SECOND DEGREE THERMAL BURNS ON BILATERAL UPPER THIGHS AND KNEES AND FIRST DEGREE BURNS ON ANTERIOR PELVIC REGION. THE PATIENT WAS ALERT, ORIENTED AND HE WAS ABLE TO RECALL ALL THE EVENTS WHICH LEAD TO INJURIES. UPON PHYSICAL EXAMINATION PUPILS WERE NORMAL AND REACTIVE MOTOR REFLEXES WERE WEAK, HOWEVER SENSORY REFLEXES WERE ABSENT ON LEFT AND RIGHT UPPER PORTION AND IT WAS NORMAL ON THE LEFT AND RIGHT LOWER PORTION OF THE BODY. GLASGOW COMA SCALE SCORE WAS 15 AND OXYGEN SATURATION WAS AT 97 PERCENT ON A NON-REBREATHER MASK. ELECTROCARDIOGRAM (ECG) REVEALED SINUS TACHYCARDIA. AT 14 44, THE PATIENT WAS TREATED WITH INTRAVENOUS 2 MG ETOMIDATE AND 80 MG ROCURONIUM. AT 14:46, THE PATENT RESPONDED TO THE TREATMENT AND THERE WE NO SPONTANEOUS RESPIRATION OR MOVEMENTS NOTED. AT 14:47, AN ATTEMPT WAS MADE TO PLACE AN OROTRACHEAL INTUBATION TUBE WHICH WAS UNSUCCESSFUL. AT 14 48, RESPIRATION WAS SUPPORTED VIA BAG VALVE MASK (BVM) WITH 15 1/MIN. AT 14:49, OROTRACHEAL INTUBATION TUBE WAS SUCCESSFULLY PLACED. THE PLACEMENT WAS VERIFIED BY AUSCULTATION, CAPNOGRAPHY, CHEST RISE AND DIRECT VISUALIZATION. AT 14 51, THE PATIENT WAS ADMINISTERED WITH INTRAVENOUS 2 MG MIDAZOLAM AND 80 MCG FENTANYL. AT 14 53, THE PATIENT WAS TRANSFERRED TO STRETCHER WITH ASSISTANCE AND HE WAS SECURED AT 14:55, THE PATIENT WAS TRANSPORTED VIA AIRCRAFT. AT 15:01, AN ADDITIONAL DOSE OF INTRAVENOUS 80 MCG FENTANYL AND 2 MG MIDAZOLAM WAS ADMINISTERED. AT 15:03, ESCHAROTOMY OF ANTERIOR CHEST WAS PERFORMED AND PATIENT WAS PLACED ON VENTILATOR. AT 15.20, THE PATIENT ARRIVED IN THE EMERGENCY DEPARTMENT. UPON ARRIVAL, THE PATIENT WAS FOUND TO HAVE HAD 7 6% TOTAL BODY SURFACE AREA DEEP PARTIAL AND FULL THICKNESS BURNS WITH MAJORITY BEING FULL THICKNESS BURNS. TRAUMA SCAN WAS NEGATIVE FOR OTHER INJURIES. FLUID RESUSCITATION WAS INITIATED, ARTERIAL AND CENTRAL VENOUS ACCESS WAS OBTAINED AND HE WAS TAKEN TO BURN UNIT WHERE CHEST WALL, NECK AND BILATERAL UPPER AND LOWER ESCHAROTOMIES WERE PERFORMED. THE PATIENT WAS CRITICALLY INJURED AND HE HAD INHALATION INJURY WITH SEVERE UPPER AIRWAY EDEMA. THE PATIENT'S VITAL SIGNS INCLUDED HEART RATE AT 154 BEATS PER MINUTE AND BLOOD PRESSURE WAS AT 114/74 MMHG. THE PATIENT UNDERWENT EXTENSIVE COVERAGE WITH ALLOGRAFT. THERE WAS PRIOR EVIDENCE OF ANGIO INVASIVE ASPERGILLUS INFECTION AND MULTIPLE GRAM-NEGATIVE RODS (GNR) BURN INFECTIONS. ON (B)(6) 2015, THE PATIENT UNDERWENT FASCIAL EXCISION AND CADAVERIC GRAFTING WITH ALLOGRAFT ON NECK, TRUNK BILATERAL UPPER AND LOWER EXTREMITIES THE PATIENT HAD A PROLONGED COMPLICATED HOSPITAL COURSE. ON (B)(6) 2015, HE DEVELOPED HYPOXEMIA. CHEST X-RAY REVEALED RIGHT LOWER LOBE PNEUMONIA AND BRONCHOSCOPY WAS CONSISTENT WITH ASPIRATION PNEUMONIA. ADDITIONAL LABORATORY RESULTS INCLUDED WHITE BLOOD CELL (WBC) AT 1.6 AND ABSOLUTE NEUTROPHIL COUNT (ANC) AT 1.3. THE PATIENT INITIALLY RECEIVED VANCOMYCIN AND ZOSYN WHICH WAS LATER CHANGED TO CEFEPIME WHEN BOTH BRONCHOALVEOLAR LAVAGE (BAL) AND BLOOD CULTURES REVEALED SERRATIA MARCESCENS. THE PATIENT'S STATUS CONTINUED TO DETERIORATE CONSISTENT WITH ACUTE RESPIRATORY DISTRESS SYNDROME. HENCE, THE PATIENT WAS ON PRESSURE REGULATED VOLUME CONTROL VENTILATION WITH INTERMITTENT NEUROMUSCULAR BLOCKADE. ON (B)(6) 2015, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR THE EXCISION OF BURNS ON THE NECK, CHEST AND ABDOMEN WITH APPLICATION OF ACELLULAR XENOGRAFT. TISSUE BIOPSIES PRIOR TO THE EXCISION SHOWED SERRATIA AND CANDIDA ALBICANS AND THE ANTIBIOTICS WERE BROADENED TO MEROPENEM AND DIFLUCAN (FLUCONAZOLE). ON (B)(6) 2015, SCATTERED AREA OF THE WOUNDS SHOWED FUNGUS THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR FURTHER DEBRIDEMENT AND PLACEMENT OF ACELLULAR XENOGRAFT ON THE TRUNK AND BILATERAL UPPER EXTREMITIES. HIS FACE AND NECK SKIN WERE EXCISED AND CADAVER SKIN TRANSPLANT WAS DONE. HIS ANTIBIOTIC REGIMEN WAS SWITCHED TO CEFTAROLINE, VORICONAZOLE AND AMPHOTERICIN. BOTH OPERATIVE CULTURE AND PATHOLOGY REVEALED INVASIVE ASPERGILLUS. HIS WOUNDS WERE PLACED IN GENTIAN VIOLET AND LATER IT WAS PLACED IN AMPHOTERICIN AND SULFAMYLON. NOREPINEPHRINE AND VASOPRESSIN WERE INTERMITTENTLY ADMINISTERED TO...