BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-D

    MDR report key: 1870707 · Received September 27, 2010

    Report

    Report Number
    1870707
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MAQUET
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    THE PT REQUIRED VENO ARTERIAL (VA) ECMO SUPPORT. AT HOUR SIX, THE MEMBRANE WAS NOTED TO HAVE A CRACK DOWN THE CENTER. THE MEMBRANE CHANGE PROCEDURE WAS EMPLOYED INCLUDING BRIEFLY SEPARATING THE PT FROM ECMO SUPPORT. THE PT REQUIRED CPR DURING THE BRIEF TIME OFF OF SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUADROX-D ECMO MEMBRANE DTZ MAQUET * 70042821

    Patients

    Seq Age Sex Outcome Treatment
    1 *