BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I ADULT WITH INTEGRATED FILTER

    MDR report key: 5882625 · Received August 17, 2016

    Report

    Report Number
    8010762-2016-00513
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 26, 2016
    Report Date
    July 27, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K082117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET (B)(4). THE PRODUCT WAS NOT REQUESTED TO RETURN FOR MANUFACTURES LABORATORY INVESTIGATION AS THE FAILURE IS KNOWN AND WAS THOROUGHLY INVESTIGATED UNDER CAPA (B)(4). THE INVESTIGATION UNDER CAPA (B)(4) IDENTIFIED THAT THE FAILURE IS CAUSED BY TOLERANCE INTERFERENCES IN CURRENT DESIGN. MAQUET CARDIOPULMONARY WILL IMPLEMENT CORRESPONDING ACTION STEPS REGARDING THE DESIGN AND TOLERANCE CRITERIA'S OF THE DIALYSIS PORT. DUE TO THIS NO FURTHER ACTION WILL BE COMPLETED AT THIS TIME. THIS COMPLAINT WILL BE CLOSED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED IS A TUBING SET AND THE INCLUDED AFFECTED COMPONENT HAS THE CONTRIBUTING DESIGN FUNCTION OF THE QUADROX-I WHICH IS REGISTERED UNDER 510(K): K082117.

    Description of Event or Problem · 1

    DESCRIPTION FROM THE CUSTOMER REPORT: "CHIEF OF PERFUSION SAID THEY HAD A OXYGENATOR WITH A LEAK OUT OF THE DIALYSIS LOCK AND VALVE. INCIDENT OCCURRED DURING PATIENT TREATMENT." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535688 QUADROX-I ADULT WITH INTEGRATED FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG VKMO 71000-USA

    Patients

    Seq Age Sex Outcome Treatment
    1