BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUADROX-I(D) ADULT

    MDR report key: 2954007 · Received January 8, 2013

    Report

    Report Number
    2954007
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 8, 2013
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    IT WAS NOTED THAT THERE WAS A SUDDEN LARGE AMOUNT OF BLOOD FLOWING FROM THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) DEVICE. IT WAS FURTHER NOTED THAT THE BONDED OXYGENATOR OUTLET HAD SPONTANEOUSLY SEPARATED FROM THE BODY OF THE OXYGENATOR.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EXTRACORPOREAL MEMBRANE OXYGENATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9465 QUADROX-I(D) ADULT OXYGENATOR, CARDIOPULMARY BYPASS DTZ MAQUET CARDIOVASCULAR LLC * 70081567

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death