BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4727299 · Received April 23, 2015

    Report

    Report Number
    8010762-2015-00373
    Event Type
    Injury
    Date Received
    April 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K101153
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR MFR'S INVESTIGATION. CLOTTING IS A KNOWN PHENOMENON AND HAS BEEN INVESTIGATED IN A PREVIOUS COMPLAINT. THE CAUSE OF THAT FAILURE WAS DETERMINED TO NOT BE ATTRIBUTED TO A DEVICE RELATED MALFUNCTION. THIS DATA WILL BE HANDLED THROUGH A DESIGNATED MAQUET TRENDING PROCESS. IF A TREND OCCURS, IT WILL BE ESCALATED TO QUALITY ASSURANCE MGMT FOR REVIEW AND DETERMINATION IF FURTHER INVESTIGATION IS NECESSARY. ADDITIONAL INFO: 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. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270627 HLM TUBING SET W/BIOLINE COATING DWE DWE MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1