BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX D DIFFUSION MEMBRANE

    MDR report key: 1823095 · Received August 13, 2010

    Report

    Report Number
    1823095
    Event Type
    Malfunction
    Date Received
    August 13, 2010
    Date of Event
    July 31, 2010
    Report Date
    August 13, 2010
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    WHILE PREPARING FOR AN ECMO PROCEDURE, THE MEMBRANE WAS NOTED TO BE CRACKED ON THE INLET SIDE. THE MEMBRANE WAS REPLACED WITHOUT COMPLICATION. IT IS UNKNOWN AS HOW THIS HAPPENED. A CRACK WAS NOTICED PRIOR TO COMMENCEMENT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX D DIFFUSION MEMBRANE DIFFUSION MEMBRANE DTZ MAQUET CARDIOVASCULAR LLC * 70041436

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR OTHER