BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID AD.O.FIL.

    MDR report key: 4366169 · Received December 9, 2014

    Report

    Report Number
    3008355164-2014-00301
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 20, 2014
    Report Date
    November 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ON ECLS AND ABOUT FOUR HOURS INTO THERAPY. THERE WAS BLOODY LIQUID COMING FROM THE GAS PORT (DEAIRING PORT). THE DEVICE WAS STILL FUNCTIONING, BUT DUE TO THE BLOOD LEAKAGE, THE DECISION WAS MADE TO CHANGE THE DEVICE. ECLS -EXTRA CORPOREAL LUNG SUPPORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796014 QUADROX-ID AD.O.FIL. BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL. DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA 70099412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention