Description of Event or Problem · 1
ON NOVEMBER 23, 1992 THE PATIENT WAS RECEIVING A MORPHINE DRIP ORDERED TO INFUSE AT THE RATE OF 1MG PER HOUR. AT APPROX. 1230 P.M. IT WAS DISCOVERED THAT THE PATIENT RECEIVED A TOTAL OF 100 MG OF MORPHINE OVER A PERIOD OF FOUR (4) HOURS.THE PATIENT WAS PRONOUNCE DEAD ON NOVEMBER 24, 1992 AT 4:00 A.M. THE PATIENT'S DEATH CERTIFICATE IDENTIFIES THE CAUSE OF DEATH AS RESPIRATORY FAILURE. THE IMED GEMINI PC-2 IV PUMP WAS IMMEDIATELY TAKEN OUT OF SERVICE . AN INDEPENDENT EVALUATION OF THE IV PUMP WAS SCHEDULED AND PERFORMED. THE FINDINGS INDICATE THAT THE IV PUMP MALFUNCTIONEDDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-OCT-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. 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, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPONENT FAILURE, MECHANICAL PROBLEM, COMPONENT FAILURE, VALVE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT, DEVICE WAS OUT OF CALIBRATION, DEVICE WAS OUT OF SPEC IN A MANNER THAT RELATES TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.