BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4253974 · Received November 13, 2014

    Report

    Report Number
    8010762-2014-01236
    Event Type
    Death
    Date Received
    November 13, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 QC 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SMALL AMOUNT OF BLOOD WAS OBSERVED LEAKING FROM THE GAS EXHAUST OF THE DEVICE DURING A POST-CARDIOTOMY ECMO CASE. THE DEVICE HAD BEEN CORRECTLY PRIMED AND DEAIRED WITH THE USUAL QUANTITY OF SALINE. LATER THE LEAKAGE SLOWED DOWN AND WAS MORE OF A PINK COLOR. TOTAL BLOOD LOSS WAS APPROX 400 ML. TOTAL ECMO TIME WAS FIVE HOURS AND 30 MINUTES. NO BLOOD TRANSFUSION WAS NEEDED. THE PT EXPIRED, BUT IT WAS REPORTED THAT THE DEATH WAS NOT RELATED TO THE LEAKAGE, BUT RATHER RELATED TO THE FORMER SURGERY. GAS EXCHANGE AND BLOOD FLOW HAD BEEN ADEQUATE DURING THE TREATMENT, DESPITE THE LEAKAGE. ECMO - EXTRA CORPOREAL MEMBRANE OXYGENATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733080 PERMANENT LIFE SUPPORT SET DWE MAQUET CARDIOPULMONARY AG BE-PLS 2050 70099512

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death