BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERMANENT LIFE SUPPORT SET

    MDR report key: 4252951 · Received November 12, 2014

    Report

    Report Number
    8010762-2014-01105
    Event Type
    Injury
    Date Received
    November 12, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 PATCH 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 (B)(4) HAS INITIATED AN INTERNAL PROCESS (CAPA (B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF NEW INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DEVICES DISPLAYED LEAKAGE AT THE GAS OUTLET DURING USE ON A PT. A THIRD DEVICE WAS USED. OXYGENATOR LOT WHICH IS INVOLVED IN THIS REPORT IS 7099261. THIS EVENT IS RELATED TO MFR REPORT # 8010762-2014-01106. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729011 PERMANENT LIFE SUPPORT SET BE-PLS 2050#PERMANENT LIFE SUPPORT SET DTQ MAQUET CARDIOPULMONARY AG BE-PLS-2050 70099572

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention