BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID ADULT O. FILTE

    MDR report key: 4203021 · Received October 23, 2014

    Report

    Report Number
    8010762-2014-00823
    Event Type
    Injury
    Date Received
    October 23, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 24, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. THE DEVICES DISPLAYED A SIMILAR MALFUNCTION WHICH WERE TESTED AND EVALUATED UNDER AN OPTICAL MICROSCOPE. DELAMINATION OF SOME GAS FIBERS WAS OBSERVED WHICH ALLOWED FOR THE PRIMING SOLUTION OR BLOOD TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE. GRAVITY THEN ALLOWED FOR PASSAGE TO THE GAS EXITING PATH ALONG THE HOUSING. THE MOST PROBABLE ROOT-CAUSE IS THE DELAMINATION OF THE HOLLOW GAS FIBERS FROM THE POLYURETHANE POTTING AREA. A REVIEW OF THE QUALITY CONTROL PROCESS CONFIRMS THAT 100% FUNCTIONAL INSPECTION FOR LEAKAGE IS PERFORMED DURING PRODUCTION. MAQUET CARDIOPULMONARY (B)(4) HAS INITIATED AN INTERNAL PROCESS (B)(4) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN NEW INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 HOURS AFTER INITIATING VENO ARTERIAL EXTRA CORPOREAL LIFE SUPPORT, CONSTANT "BLOOD TINGED" DROPS WERE NOTED COMING FROM THE VENT PORT AT BOTTOM OF DEVICE. FLOW RATE THROUGH THE DEVICE WAS 3.5-4 LITERS/MINUTE. THE GAS EXCHANGE WAS ADEQUATE AND FUNCTIONING PROPERLY. THE HEAT EXCHANGE COMPONENT WAS FUNCTIONING ADEQUATELY. THE RATE OF THE LEAK WAS NOT SLOWING DOWN AND WAS DESCRIBED TO BE 1-2 DROPS PER MINUTE AND BECOMING MORE BLOOD-TINGED. THE DEVICE WAS CHANGED OUT WITH NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674901 QUADROX-ID ADULT O. FILTE DIFFUSIVE MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HMOD 70000-USA 70099027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention