BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA-AORTIC BALLOON

    MDR report key: 17341 · Received September 15, 1994

    Report

    Report Number
    17341
    Event Type
    Death
    Date Received
    September 15, 1994
    Date of Event
    August 31, 1994
    Report Date
    September 14, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IABP INSERTED DURING VALVE SURGERY ON 9/29/94. ON 9/31/94, BRIGHT RED BLOOD NOTED IN IABP TUBING; TUBING CLAMPED. PUMP TURNED OFF. PT EXPERIENCED DECREASE IN BLOOD PRESSURE AND NO PULSE. CPR INITIATED. PT TRANSPORTED IMMEDIATELY TO OR. HAD OPEN CARDIAC MASSAGE AND REMOVAL AND REINSERTION OF BALLOON. PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON Implant INTRA-AORTIC BALLOON DSP KONTRON INSTRUMENTS, INC. 40 CC E4N 3300 9.0F

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death DATASCOPE SYSTEM 97 INTRA-AORTIC BALLOON PUMP.