BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADROX-ID

    MDR report key: 4188766 · Received October 17, 2014

    Report

    Report Number
    8010762-2014-00814
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 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 OF 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 AG HAS INITIATED AN INTERNAL PROCESS (CAPA-(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 MINUTES AFTER INITIATING VA ECLS (VENO-ARTERIAL EXTRACORPOREAL LIFE SUPPORT), CONSISTENT BLOOD DROPS WERE NOTED COMING FROM THE VENT PORT AT BOTTOM OF OXYGENATOR. FLOW RATE THROUGH THE OXYGENATOR WAS 3LITERS/MIN. THE GAS EXCHANGE WAS ADEQUATE AND FUNCTIONING PROPERLY, HEAT EXCHANGE COMPONENT WERE FUNCTIONING ADEQUATELY AS WELL. THE RATE OF BLOOD LEAKAGE WAS NOT SLOWING DOWN. THE PERFUSIONIST DESCRIBED THE RATE AS "1-2 DROPS PER MINUTE". A DECISION WAS MADE TO EXCHANGE THE OXYGENATOR. THE OXYGENATOR WAS CHANGED OUT WITHOUT DIFFICULTY OR INCIDENT TO THE PATIENT. THIS PATIENT WAS ON ECLS SUPPORT FOR 5 DAYS PRIOR TO BEING TAKEN TO THE OPERATING ROOM FOR VALVE SURGERY. THE SURGERY WAS COMPLETED AND PATIENT PLACED BACK ONTO ECLS SUPPORT. THE INCIDENT DESCRIBED ABOVE OCCURRED IN THE OPERATING ROOM WHEN THE PATIENT WAS PLACED BACK ONTO ECLS SUPPORT. A FLUID LEAK WAS NOT OBSERVED DURING THE PRIMING OF THE NEW CIRCUIT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661289 QUADROX-ID OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG HMOD 70000-USA 70099027

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention