BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4208745 · Received October 22, 2014

    Report

    Report Number
    8010762-2014-00817
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    MWJ
    PMA / PMN Number
    K102723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS ON AN ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION) PATIENT FOR A PERIOD OF FIVE DAYS. DURING THIS TIME, A PINK SOLUTION (AS IF CONDENSATION) WAS OBSERVED COMING OUT FROM THE BOTTOM OF THE DEVICE. PRESSURE PARAMETERS WERE NORMAL THROUGHOUT TREATMENT. THE DEVICE WAS NOT SWAPPED OUT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674312 CARDIOHELP SYSTEM TUBING SET MWJ MAQUET CARDIOPULMONARY AG BE-PLS 2051 70097053

    Patients

    Seq Age Sex Outcome Treatment
    1