BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXGENERATOR W INTEGRATED HEAT EXCHANGER

    MDR report key: 4425399 · Received January 13, 2015

    Report

    Report Number
    8010762-2014-01398
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 16, 2014
    Report Date
    December 16, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS. THE DEVICE 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 PERCENT 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 NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER INITIATING ECLS SUPPORT DURING A TRANSPORT, A SMALL AMOUNT OF BLOOD WAS OBSERVED DRIPPING OUT OF THE GAS EXHAUST PORT. ECLS - EXTRA CORPOREAL LUNG SUPPORT. REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28081 OXGENERATOR W INTEGRATED HEAT EXCHANGER DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1