Description of Event or Problem · 1
3/24/92- PROFOUNDLY RETARDED YOUTH WITH SEVERE CEREBRAL PALSY WAS BEING OPERATED ON TO CORRECT KYPHOSCOLIOSIS - LUGUE RODS INSTRUMENTATION. DURING THE PROCEDURE THE COBE BRAT CELL WASHER WAS USED. PATIENT STARTED TO HEMMORRHAGE AND THEN EXPERIENCED CARDIAC ARREST. PATIENT WAS RESUSCITATED, HOWEVER ARRESTED AGAIN AND EXPIRED. ON 4/3/92 THE AUTOSPY RESULTS INDICATED: "BECAUSE A DIRECT COOMBS TEST WAS DONE ON THE INTRAOPERATIVE BLOOD SAMPLE AND WAS NEGATIVE, I BELIEVE THE COBE CELL SAVER IS THE LIKELY CAUSE OF THE HEMOLYSIS AND DIC IN THIS PATIENT. DIC AND HEMOLYSIS ARE WELL KNOWN ADVERSE EFFECTS OF INTRAOPERATIVE CELL SAVERS WHICH HAVE BEEN WELL DESCRIBED IN THE LITERATURE"DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-MAR-92. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.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, VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, INHERENT RISK OF PROCEDURE. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.