BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BE-HLS 7050#HLS SET ADVANCED 7.0

    MDR report key: 4340115 · Received December 9, 2014

    Report

    Report Number
    8010762-2014-01333
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 7, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K1011153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY AG 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 RECEIVE FROM THE HOSPITAL, THE MOST PROBABLE ROOT CAUSE IS DELAMINATION OF SOME GAS FIBERS FROM THE POLYURETHANE POTTING AREA. (B)(4) 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 CONTINOUS MONITORING OF UPCOMING COMPLAINTS FOR TRENDS. ADDITIONAL INFO: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-ICD WHICH IS REGISTERED UNDER 510(K): K1011153.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ECMO A LEAK WAS NOTED AT THE GAS EXHAUST PORT OF THE DEVICE. NO LEAK WAS OBSERVED DURING PRIMING. THE LEAK STOPPED AT A LATER POINT. THE THERAPY CONTINUED. ECMO - EXTRA CORPOREAL MEMBRANE OXYGENATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797169 BE-HLS 7050#HLS SET ADVANCED 7.0 TUBING SET DTQ MAQUET CARDIOPULMONARY AG 70100079

    Patients

    Seq Age Sex Outcome Treatment
    1