BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 359920 · Received November 6, 2001

    Report

    Report Number
    2021710-2001-00146
    Event Type
    Malfunction
    Date Received
    November 6, 2001
    Date of Event
    February 7, 2001
    Manufacturer
    BIRD PRODUCTS CORP.
    Product Code
    MNJ
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGEN CANNULATION. TO PREVENT OVER-PRESSURIZATION TO THE PT, A POP-OFF WAS USED TO FIT IN THE OXYGENATOR GAS LINE. THE CO2 IN THE PT'S BLOOD ELEVATED, BEFORE AND AFTER OXYGENATION. WHEN THE POP OFF VALVES WERE FROM ALL CIRCUITS, THE PCO2 LEVEL ON THE PT AND THE ECMO CIRCUIT DECREASED. THE POP-OFF VALVES WERE MEASURED AND RECORDED TO POP OFF AT 30CMH2O.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49569 * * MNJ BIRD PRODUCTS CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 DAY