BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050 PERMANENT LIFE SUPPORT SET

    MDR report key: 4356058 · Received December 17, 2014

    Report

    Report Number
    8010762-2014-01347
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 24, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 HOSP. THEREFORE, WE WILL NOT BE ABLE TO CONFIRM THE FAILURE. BASED ON THE FAILURE DESCRIPTION RECEIVED FROM THE HOSP, THE MOST PROBABLE ROOT CAUSE IS DELAMINATION OF SOME GAS FIBERS FROM THE POLYURETHANE POTTING AREA. MAQUET CARDIOPULMONARY AG HAS INITIATED AN INTERNAL PROCESS ((B)(4)) TO ADDRESS THE APPROPRIATE CORRECTIVE AND PREVENTIVE ACTION. WE WILL CONTINUE TO ADDRESS THE MOST PROBABLE ROOT CAUSE THROUGH THE (B)(4), AS WELL AS CONTINUOUSLY MONITOR UPCOMING COMPLAINTS FOR TRENDS. ADD'L INFO: 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 OBSERVED THAT A FEW HRS AFTER IMPLEMENTATION OF THE DEVICE, BLOOD LEAKAGE AS DROPS WERE OBSERVED AT THE GAS OUTLET. THE LEAK DRIED UP AFTER APPROXIMATELY 20 HOURS. BLOOD LOSS WAS LESS THAN 5ML. THE DEVICE WAS NOT REPLACED DUE TO THE PT'S CONDITION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829936 BE-PLS 2050 PERMANENT LIFE SUPPORT SET TUBING SET DTZ MAQUET CARDIOPULMONARY AG 70099616

    Patients

    Seq Age Sex Outcome Treatment
    1