BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID ADULT DIFFUSION MEMBRAN OXYGENATOR

    MDR report key: 4752325 · Received May 5, 2015

    Report

    Report Number
    3008355164-2015-00090
    Event Type
    Injury
    Date Received
    May 5, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 7, 2015
    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 THE DEVICE BEGAN TO DRIP BLOOD (10CC) FROM THE ARTERIAL OUTLET SIDE. THE DEVICE WAS EXCHANGED. (B)(4). REF MFR# 8010762-2015-00426.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292282 QUADROX-ID ADULT DIFFUSION MEMBRAN OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70102583

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention