BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS MODULE ADVANCED ADULT

    MDR report key: 3242623 · Received July 19, 2013

    Report

    Report Number
    8010762-2013-00035
    Event Type
    Death
    Date Received
    July 19, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K102627
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MFR OF THE DEVICE (B)(4). PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. COMPLETE PERFORMANCE TESTING WAS CONDUCTED ON THE RETURNED SAMPLE WHICH INCLUDED THE GAS TRANSFER TEST AND THE PRESSURE DROP TEST ON THE BLOOD SIDE. ALL RESULTS WERE WITHIN THE REQUIREMENTS. NO CLOTTING WAS OBSERVED UNDER TEST CONDITIONS. PRODUCTION RECORDS FOR THE COATING PROCESS WERE REVIEWED AND NO DEVIATIONS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM CLOTTED AFTER A FEW MINS OF USE DESPITE FULL HEPARINIZATION. THE FILM OF THE ANGIOGRAM SHOWED CLOTS INSIDE THE PTS VESSEL. THE PTS EJECTION FACTOR WAS APPROX 5 PERCENT. CLOTS OCCURRED EITHER DUE TO HITT (HEPARIN-INDUCED THROMBOCYTOPENIC THROMBOSIS) OR LOW PERFUSION PRIOR TO THE HEPARIN BEING ADMINISTRATED. THE PT EXPIRED WHILE ON ANOTHER SUPPORT DEVICE SHORTLY AFTER THIS EVENT. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338860 HLS MODULE ADVANCED ADULT OXYGENATOR DTZ MAQUET CARDIOPULMONARY AG HLS MODULE ADVANCED 70086876

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death