BEUDAMED
    FDA Adverse Event Death Summary report: N

    90 T INTRA AORTIC BALLOON PUMP

    MDR report key: 7418 · Received February 23, 1994

    Report

    Report Number
    7418
    Event Type
    Death
    Date Received
    February 23, 1994
    Date of Event
    February 16, 1994
    Report Date
    February 22, 1994
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PT WITH A HISTORY OF AORTIC STENOSIS, COPD, STATUS POST R LOWER LOBECTOMY FROM 1972 DX OF BRONCHOGENIC CA AND POST OP RADIATION, CHRONIC CHF, CEREBRAL INSUFFICIENCY AND MILD DEMENTIA, EPISODE OF ACUTE DELIRIUM ON HIGH DOSE STEROIDS WAS SCHEDULED FOR A MITRAL AND AORTIC VALVE REPLACEMENT. SURGERY BEGAN AT 0720 AND AFTER COMING OFF BYPASS, PT WAS NOT PERFUSING WELL AND IABP WAS INSERTED. BALLOON PUMP INSERTED IN USUAL MANNER WITHOUT DIFFICULTY, EKG AND PRESSURE WAS HOOKED UP. PT WAS PACEMAKER DEPENDENT. PUMP SHOWED GOOD WAVE ORM. IABP TURNED ON TRIGGER MODE-EKG. IABP MONITOR SCOPE INDICATED "NO TRIGGER." CHANGED TRIGGER MODE TO "PRESSURE." IABP TRIGGERED OFF PRESSURE CURVE FOR A FEW MINS AND THEN STOPPED. AFTER THAT THE IABP WOULD WORK INTERMITTENTLY. ANOTHER MEMBER OF THE TEAM FELT THAT THE PUMP WHILE OPEN HEART MESSAGE WAS BEING DONE, THE MACHINE REGISTERED AS TRIGGERING, BUT WHEN MESSAGE WAS STOPPED, THE NO TRIGGER MESSAGE WAS OCCURRING. WHEN THE DIFFICULTY WAS BEING ENCOUNTERED, THE ENTIRE MACHINE, CABLES, LEADS, EKG PATCHES, AND HEPARINIZED SOLUTION WERE CHANGED. THE SAME MESSAGE OCCURRED AND ALSO WAS INTERMITTENTLY GONE DURING TIMES OF INTERNAL MESSAGE. AUGMENTATION ONLY OCCURRED AS THE OPEN HEART MESSAGE WAS BEING PERFORMED. THE MACHINE WAS THEN CHANGED BACK TO THE ORIGINAL ONE AND THE SAME SCENARIO OCCURRED. THE PHYSICIAN PRONOUNCED THE PT DEAD AT 1235 ON 2/16/94. MONITOR PART # 0997-0175-01, PART OF SYSTEM #0998-00-0060-01 AND PUMP PART # 0997-00-0171-01.DEVICE 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-JAN-94. 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, ELECTRICAL TESTS PERFORMED, MECHANICAL TESTS PERFORMED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90 T INTRA AORTIC BALLOON PUMP IABP DSP DATASCOPE 90 T

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death