BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-PLS 2050 #PERMANENT LIFE SUPPORT SET

    MDR report key: 4470319 · Received January 29, 2015

    Report

    Report Number
    8010762-2015-00015
    Event Type
    Malfunction
    Date Received
    January 29, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING A SIMILAR MALFUNCTION HAVE BEEN TESTED UNDER THE OPTICAL MICROSCOPE AND DELAMINATION OF SOME GAS FIBERS WAS OBSERVED. HENCE, THE PRIMING SOLUTION OR BLOOD WAS ABLE TO FLOW INSIDE THE GAP BETWEEN THE GAS FIBERS AND POLYURETHANE AND GRAVITY GUIDED IT 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. OUR INVESTIGATIONS HAVE SHOWN THAT IF THE FIBERS HAVE SEPARATED FROM THE POLYURETHANE CASTING PRIOR TO FINAL RELEASE, WE WOULD IDENTIFY AND REJECT THE INDIVIDUAL PRODUCTS AS HAVING A LEAK DURING OUR 100% FINAL INSPECTION. THIS SEPARATION OCCURS AT SOME POINT DURING THE LIFE OF THE PRODUCT. OXYGENATORS THAT HAVE BEEN INVOLVED IN COMPLAINTS TO DATE, SHOW NO DIRECT RELATION BETWEEN THE AGE OF THE OXYGENERATOR AND THE OCCURRENCE OF THE FAILURE, HOWEVER, THE AGE OF THE PRODUCT DOES HAVE A POTENTIAL INFLUENCE ON THE OCCURRENCE OF LEAKAGE. POTENTIAL CAUSES ARE CURRENTLY BEING INVESTIGATED. MAQUET CARDIOPULMONARY (B)(4) INITIATED CUSTOMER NOTIFICATION (FSCA 2014-12-11) CONCERNING THE PROBLEM, THE POTENTIAL RISKS AND THE RECOMMENDATION IN HANDLING IN THE EVENT THIS FAILURE OCCURS. ADDITIONAL INFO: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE UNITED STATES, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QUADROX-ID) IS REGISTERED UNDER 510(K): (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THERAPY BLOOD LEAKAGE FROM THE OUTLET CONNECTOR WAS OBSERVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68379 BE-PLS 2050 #PERMANENT LIFE SUPPORT SET TUBING -SET, DIFFUSIVE MEMBRANE OXYGENERATOR DTZ MAQUET CARDIOPULMONARY AG 70102.7818 70099748

    Patients

    Seq Age Sex Outcome Treatment
    1