BEUDAMED
    FDA Adverse Event Death Summary report: N

    BEQ-01970311# BEQ-QUADROX-ID AD.O.FILTE

    MDR report key: 3854145 · Received May 20, 2014

    Report

    Report Number
    3008355164-2014-00102
    Event Type
    Death
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER INITIATING ECMO THE CLINICIAN NOTICED SLIGHT DROPS OF BLOOD DRIPPING FROM THE CONDENSATION PORT ON THE BOTTOM OF THE OXYGENATOR. THE UNIT WAS CHANGED OUT. THE PT LATER EXPIRED, BUT NOT AS A RESULT OF THIS INCIDENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298985 BEQ-01970311# BEQ-QUADROX-ID AD.O.FILTE DIFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70095967

    Patients

    Seq Age Sex Outcome Treatment
    1 Death