BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBIN GSET W/BIOLINE COATING

    MDR report key: 4553423 · Received February 25, 2015

    Report

    Report Number
    8010762-2015-00101
    Event Type
    Injury
    Date Received
    February 25, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 27, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REQUESTED FOR EVALUATION. THE INVESTIGATION IS STILL PENDING. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION: THE PRODUCT MENTIONED UNDER SECTION D IS A TUBING SET AND 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

    IT WAS REPORTED THE DEVICE WAS BROKEN WHICH CAUSED BLOOD LEAKAGE DURING USE. THE DEVICE WAS CHANGED OUT, WHICH DELAYED TREATMENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131963 HLM TUBIN GSET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG BE-PLS 2050 70097043

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention