BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050# PERMANENT LIFE SUPPORT SET

    MDR report key: 4349401 · Received December 11, 2014

    Report

    Report Number
    8010762-2014-01337
    Event Type
    Malfunction
    Date Received
    December 11, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 20, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTR
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY (B)(4) WILL NOT BE ABLE TO OBTAIN THE PRODUCT BACK FOR INVESTIGATION, FOR THE PRODUCT WAS DISCARDED BY THE HOSPITAL. THEREFORE, WE WILL NOT BE ABLE TO CONFIRM THE FAILURE. BASED ON THE FAILURE DESCRIPTION RECEIVED FROM THE HOSPITAL, THE MOST PROBABLE ROOT CAUSE IS DELAMINATION OF SOME GAS FIBERS FROM THE POLYURETHANE POTTING AREA. MAQUET CARDIOPULMONARY AG HAS INITIATED A CAPA PROCESS ((B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. THE MOST PROBABLE ROOT-CAUSE WILL BE TRACKED THROUGH (B)(4), AS WELL AS CONTINUOUS MONITORING OF UPCOMING COMPLAINTS FOR TRENDS. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ID WHICH IS REGISTERED UNDER 510 (K): K101153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW DROPS OF BLOOD WERE OBSERVED LEAKING FORM THE GAS EXHAUST OF THE DEVICE DURING THE FIRST DAY OF TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806918 BE-PLS 2050# PERMANENT LIFE SUPPORT SET BE-PLS 2050 DTR MAQUET CARDIOPULMONARY AG 70102.7818 70099571

    Patients

    Seq Age Sex Outcome Treatment
    1