Description of Event or Problem · 1
THE PT WAS BORN ON 8/17/93 TO A 15-YR-OLD, GRAVIDA 1, PARA 1 BY CASEAREAN SECTION. THE INFANT WAS NOTED AT BIRTH TO HAVE LEFT SIDED DIAPHRAGMATIC HERNIA WITH SEVERE RESPIRATORY FAILURE. INITIAL VENTILATOR MANAGEMENT WAS UNSUCCESSFUL AND THE CHILD WAS REFERRED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ON 8/18/93, THE CHILD WAS EMERGENTLY PLACED ON VENO-ARTERIAL ECMO UTILIZING A STANDARD ECMO CIRCUIT. IT WAS DECIDED THAT THE CARMEDA COATED CIRCUIT WOULD BE UTILIZED 12 HRS PRIOR TO OPERATION IN ORDER TO DECREASE THE INCIDENCE OF INTRAOPERATIVE BLEEDING. THE PROTOCOL AS OUTLINED IN THE IRB PROPOSAL WAS FOLLOWED EXACTLY AND THE PT WAS PLACED ON THE CARMEDA CIRCUIT PRIOR TO OPERATIVE REPAIR. ON 8/20/93, THE PT UNDERWENT A GORETEX PATCH REPAIR OF A LARGE LEFT DIAPHRAGMATIC HERNIA WITHOUT INCIDENT. RPTR CONTINUED TO GIVE LOW DOSES OF HEPARIN AS DESCRIBED IN THE PROTOCOL. BLOOD CLOTS WERE NOTED IN THE CIRCUIT AND WERE RECORDED AS A MATTER OF OBSERVATION. THE PRESENCE OF CLOTS WITHIN THE CIRCUIT IS A COMMON EVENT DURING ECMO, BUT EMBOLI ARE A RARE EVENT. OVER THE FOLLOWING THREE DAYS, THE PT DID QUITE WELL. ON 8/22/93, THE BABY HAD THREE TOES ON THE LEFT FOOT THAT APPEARED TO HAVE "BLUE TOE SYNDROME." SUCH EVENTS HAVE BEEN NOTED IN THE PAST, IN NEONATES WITH UMBILICAL ARTERY CATHETERS (CALLED CATHETER TOE). THIS WAS CAREFULLY FOLLOWED AND FELT TO BE AN UNCHANGING SITUATION OVER THE NEXT 24 HRS. ON THE EVENING OF 8/23/93, THE "BLUE TOE SYNDROME" ON THE LEFT FOOT HAD PROGRESSED TO INCLUDE THE RIGHT FOOT. THE CIRCUIT WAS CHANGED TO A REGULAR ECMO CIRCUIT REQUIRING FULL HEPARINIZATION. CO REP WAS ALERTED OF THE MAJOR ADVERSE EVENT AT 11:00 PM ON 8/23/93. ON 8/24/93, THE BABY WAS NOTED BY ECHO DOPPLER, TO HAVE NO BLOOD FLOW TO THE RIGHT KIDNEY, AND INCOMPLETE CLOT IN THE ABDOMINAL AORTA REGION OF THE RENAL ARTERIES, GOOD BLOOD FLOW TO THE LEFT KIDNEY, GOOD BLOOD FLOW TO THE DISTAL AORTA AND ILIACS AND CEREBRAL FLOW WAS FELT TO BE NORMAL. SURGERY WAS PERFORMED 8/27/93, FINDING NECROTIC AND PERFORATED BOWEL; THE INFANT WAS REMOVED FROM ECMO AND WAS PRONOUNCED DEAD AT 2045 ON 8/27/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.