BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4152394 · Received October 3, 2014

    Report

    Report Number
    8010762-2014-00776
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 ((B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRIMING THERE WAS IMMEDIATE LEAKAGE OF PRIMING FLUID (PLS PRIMING CONTAINS RINGERLACTAAT WITH 2500 UNITS HEPARIN) FROM THE GAS OUTLET OF THE DEVICE. APPROX 300MMHG WERE PRESSED ON TO THE SYSTEM TO CHECK TIGHTNESS AND REMOVE ANY REMAINING AIR. THERE WAS NO DELAY IN PT CARE. SET WAS NOT USED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617554 PERMANENT LIFE SUPPORT SET BE-PLS 2050#PERMANENT LIFE SUPPORT SET DTZ MAQUET CARDIOPULMONARY AG BE-PLS 2050 70097016

    Patients

    Seq Age Sex Outcome Treatment
    1