BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMOD 70000-USA#QUADROX-ID ADULT

    MDR report key: 3870166 · Received May 21, 2014

    Report

    Report Number
    3008355164-2014-00103
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    April 18, 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
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OXYGENATOR HAD TO BE CHANGED LESS THAN 24 HOURS INTO THE RUN. ANTI-XA, APTT, TEG, ATIII LEVELS ALONG WITH ACT, PLATELET COUNT AND FIBRINOGEN LEVELS WERE BEING OBSERVED. ALL APPEARED FINE WHEN A CLOT ON THE OXY SIDE (ARTERIAL SIDE) RAPIDLY APPEARED. NO INJURY TO THE PATIENT WAS REPORTED. (B)(4). REFERENCE MFR # 8010762-2014-00208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303021 HMOD 70000-USA#QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70093818

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Required Intervention