BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARROW INTERNATIONAL IABP

    MDR report key: 210003 · Received February 5, 1999

    Report

    Report Number
    210003
    Event Type
    Death
    Date Received
    February 5, 1999
    Date of Event
    January 28, 1999
    Report Date
    February 2, 1999
    Manufacturer
    ARROW INTERNATIONAL
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS A 79 YEAR OLD STATUS POST MITRAL VALVE REPLACEMENT. INTRA AORTIC BALLOON PULSATION DEVICE WAS PLACED 1-27-99. ON 1-28-99 PATIENT WAS TAKEN TO SURGERY FOR EMERGENCY REMOVAL OF IABP. IABP WAS NOTED TO HAVE ALOT OF ACCUMULATION OF BLOOD (LARGE CLOT) IN ITS LUMEN & READINGS WERE CONSISTENT WITH THAT OF A MALFUNCTIONING BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW INTERNATIONAL IABP 9 FR 40CC INTRA-AORTIC BALLOON PUMP DSP ARROW INTERNATIONAL IAB-04240 073198

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death