BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET

    MDR report key: 4997078 · Received August 11, 2015

    Report

    Report Number
    8010762-2015-00875
    Event Type
    Death
    Date Received
    August 11, 2015
    Report Date
    December 16, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) IS NOT ABLE TO PERFORM AN INVESTIGATION SINCE THE DEVICE IS NOT AVAILABLE. CLOTTING IS A KNOWN PHENOMENON TO MAQUET CARDIOPULMONARY (B)(4). ANTICOAGULATION HAS MANY DIVERSE FACTORS WHICH ARE INFLUENCED BY MEDICATION AND EACH PATIENT'S INDIVIDUAL SYSTEM. BASED ON THE INFORMATION AVAILABLE AT THIS TIME, A FAILURE CONFIRMATION IS NOT POSSIBLE. IF FURTHER INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4). REFERENCE UF/IMPORTER # 3008355164-2015-00156.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523454 HLM TUBING SET DTZ MAQUET CARDIOPULMONARY AG 70105.2794

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Death