BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.

    MDR report key: 4150822 · Received September 9, 2014

    Report

    Report Number
    8010762-2014-00350
    Event Type
    Injury
    Date Received
    September 9, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K132829
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION OF 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WAS BLOOD TO GAS LEAKAGE OF APPROX 5 ML, WHEN THE DEVICE WAS IN USE. THE DEVICE WAS EXCHANGED FOR ANOTHER WITH NO REPORTED PT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556163 BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL. DIFFUSION MEMBRANE OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG BEQ-HMOD70000 70099415

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention