BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4404276 · Received January 8, 2015

    Report

    Report Number
    8010762-2014-01390
    Event Type
    Death
    Date Received
    January 8, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 10, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 QUAL 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 INFO BECOMES AVAILABLE. ADD'L INFO: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510 (K): K101153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS RECEIVED WITH SEVERE PNEUMONIA. ECMO WAS INITIATED AT 13:00 PM ON (B)(6) 2014. BLOOD WAS OBSERVED LEAKING FROM THE CO2 OUTLET OF THE DEVICE. ON (B)(6) 2014, 13:00 PM THE PT EXPIRED. TOTAL ESTIMATED BLOOD LOSS WAS APPROX 300 ML. A BLOOD TRANSFUSION WAS ADMINISTERED DURING ECMO SUPPORT. THE SET WAS NOT REPLACED DUE TO THE PT'S CONDITION. THE DEATH IS NOT BEING ASSOCIATED WITH THE DEVICE, BUT RATHER THE SEVERE PNEUMONIA. ECMO: EXTRA CORPOREAL MEMBRANE OXYGENATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17343 PERMANENT LIFE SUPPORT SET BE-PLS 2050 PERMANENT LIFE SUPPORT SET DTZ MAQUET CARDIOPULMONARY AG BE-PLS 2050 70099516

    Patients

    Seq Age Sex Outcome Treatment
    1 Death