BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC AFFINITY NT

    MDR report key: 255711 · Received December 17, 1999

    Report

    Report Number
    255711
    Event Type
    Injury
    Date Received
    December 17, 1999
    Date of Event
    December 10, 1999
    Report Date
    December 16, 1999
    Manufacturer
    MEDTRONIC CARDIAC SURGERY
    Product Code
    DTZ
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OXYGENATOR IN MEDTRONIC AFFINITY NT HAD CRACK/HOLE IN PLASTIC HOUSING. CRACK WAS LOCATED ON TOP EDGE OF PLASTIC HOUSING UNDERNEATH THE SKIRT OF THE VENOUS RESERVOIR, SO WAS NOT VISIBLE WHEN UNIT SET-UP. PT'S SV02 DROPPED TO 40% AND PROBLEM WITH OXYGENATOR WAS DISCOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC AFFINITY NT OXYGENATOR DTZ MEDTRONIC CARDIAC SURGERY OE82R7 9908000091

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R