BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-PUMP

    MDR report key: 102718 · Received June 30, 1997

    Report

    Report Number
    2124837-1997-00014
    Event Type
    Malfunction
    Date Received
    June 30, 1997
    Date of Event
    April 30, 1997
    Report Date
    June 27, 1997
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    KFM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT 15 HOURS INTO RIGHT VENTRICULAR SUPPORT, THE BIO-PUMP BEGAN TO LEAK. THE BIO-PUMP WAS REPLACED WITH ANOTHER BIO-PUMP TO CONTINUE WITH NO EFFECT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-PUMP EXTRACORPOREAL CENTRIFUGAL BLOOD PUMP KFM MEDTRONIC BIO-MEDICUS, INC. BP-80 9602000631

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other