BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4635877 · Received March 25, 2015

    Report

    Report Number
    8010762-2015-00297
    Event Type
    Injury
    Date Received
    March 25, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTZ
    PMA / PMN Number
    K101153
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE REPORTED EVENT AND OUR INVESTIGATION, THE REPORTED EVENT WAS CAUSED BY USE THAT IS BEYOND THE USAGE DESCRIBED IN OUR LABELING AND CLEARED INTENDED USE. THE CUSTOMER WILL BE ADVISED TO FOLLOW THE INSTRUCTIONS PROVIDED BY THE MFR IN THE IFU. THE PRODUCT MENTIONED UNDER SECTION D 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. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.(B)(4).

    Description of Event or Problem · 1

    IMP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201076 HLM TUBING SET W/BIOLINE COATING DTZ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1