BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-HQV 57104#CUSTOM PACK

    MDR report key: 4113699 · Received September 17, 2014

    Report

    Report Number
    8010762-2014-00347
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 19, 2014
    Report Date
    August 20, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. 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 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 AFTER INITIATION OF PERFUSION, BLOOD LEAKAGE FROM THE GAS OUTLET PORT WAS OBSERVED. PERFUSION TIME WAS 55 MINUTES AND DURING THIS PERIOD THE DEVICE WAS FULLY FUNCTIONAL IN TERMS OF OXYGENATION AND VENTILATION. THE DEVICE WAS NOT CHANGED OUT. TOTAL BLOOD LOSS WAS APPROXIMATELY 7-8 ML. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575826 BE-HQV 57104#CUSTOM PACK DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG 70098508

    Patients

    Seq Age Sex Outcome Treatment
    1