BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERCOR-STAT INTRA-AORTIC BALLOON

    MDR report key: 1388 · Received September 14, 1992

    Report

    Report Number
    1388
    Event Type
    Death
    Date Received
    September 14, 1992
    Date of Event
    August 20, 1992
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS THREE DAYS POST-OP OF A MITRAL VALVE REPLACEMENT WITH A FEMORAL INTRA-AORTIC BALLOON PUMP AND A CORONARY ARTERY BYPASS GRAFT. THE INTRA-AORTIC BALLOON PUMP RUPTURED CAUSING BLOOD IN THE TUBING BACKED UP TO THE SAFETY CHAMBER. THE PUMP WAS REMOVED SURGICALLY AND NOT REPLACED. THE PATIENT'S CONDITION WAS CRITICAL AFTER INITIAL SURGERY. IT IS UNCLEAR IF THE BALLOON RUPTURE WAS A CONTRIBUTING FACTOR OF THE DEATH OF THIS PATIENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCOR-STAT INTRA-AORTIC BALLOON INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORPORATION 0684-00-0212-04

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death