BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLM TUBING SET

    MDR report key: 5053894 · Received September 3, 2015

    Report

    Report Number
    8010762-2015-01028
    Event Type
    Death
    Date Received
    September 3, 2015
    Date of Event
    August 10, 2015
    Report Date
    March 22, 2016
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/03/2015 (B)(4). MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # (B)(4). 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.

    Description of Event or Problem · 1

    TWO SMALL AREAS OF THROMBUS WERE IDENTIFIED ON THE 2 LATERAL EDGES ON THE BLOOD OUTLET SIDE OF THE QUADROX-ID OXYGENATOR. CLINICAL DECISION WAS MADE NOT TO EXCHANGE THE DEVICE AS THE DEVICE WAS FUNCTIONING PROPERLY. ADDITIONAL INF RECEIVED AUG 31,2015: AS OF LATE FRIDAY AFTERNOON (B)(6) 2015, THE HLS DISPOSABLE WAS STILL BEING UTILIZED WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584845 HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY AG BO-HLS 7050 USA 70091076

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| R| D