BEUDAMED
    FDA Adverse Event Summary report: N

    DISPOSABLE BIOPUMP

    MDR report key: 17113 · Received October 24, 1994

    Report

    Report Number
    MW1003780
    Date Received
    October 24, 1994
    Date of Event
    September 13, 1994
    Report Date
    October 13, 1994
    Manufacturer
    MEDTRONIC BIO-MEDICUS, INC.
    Product Code
    DWB
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRACKS IN PLASTIC MATERIAL AROUND BEARINGS RESULTING IN POTENTIAL FOR FAILURE OF BLOOD PUMP AND REQUIRING PREMATURE TERMINATION OF BYPASS. NO PT INJURY ALTHOUGH DEFECT COULD POTENTIALLY BE LIFE THREATENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE BIOPUMP DISPOSABLE BIOPUMP DWB MEDTRONIC BIO-MEDICUS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 *