BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL

    MDR report key: 4580397 · Received March 4, 2015

    Report

    Report Number
    3008355164-2015-00024
    Event Type
    Injury
    Date Received
    March 4, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 4, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE LEAKED BLOOD FROM THE GAS PORT. THE DEVICE WAS REPLACED. NO REPORTED PATIENT EFFECT. (B)(4). MFR REF # 8010762-2015-00078.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152468 BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL DIFFUSION MEMBRANE OXYGENATOR DTM MAQUET CARDIOPULMONARY AG 70105.3824 70100709

    Patients

    Seq Age Sex Outcome Treatment
    1 Other