BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HLM TUBING SET W/BIOLINE COATING

    MDR report key: 4941866 · Received July 23, 2015

    Report

    Report Number
    8010762-2015-00837
    Event Type
    Injury
    Date Received
    July 23, 2015
    Date of Event
    June 22, 2015
    Report Date
    July 9, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K080592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CLOTTING IS A KNOWN PHENOMENON TO MAQUET CARDIOPULMONARY AND HAS BEEN THOROUGHLY INVESTIGATED IN A PREVIOUS COMPLAINT. A VISUAL INSPECTION OF THE RECEIVED PICTURES SHOWED CLOTTING IN THE TUBE. THE DATA IS BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SOME CLOT FORMATION WAS OBSERVED UNDER THE PLACE OF THE VENOUS BUBBLE SENSOR, WHEN THE VENOUS BUBBLE SENSOR WAS MOVED FOR SOME OTHER REASON. PHOTOS ATTACHED. SYSTEM FUNCTIONED WELL THROUGH WHOLE TREATMENT. CLOTTING SEEMED TO DISAPPEAR GRADUALLY AFTERWARDS AND NO NEW CLOTTING WAS OBSERVED UNDER THE NEW PLACE OF VENOUS BUBBLE SENSOR. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478604 HLM TUBING SET W/BIOLINE COATING DWE MAQUET CARDIOPULMONARY AG BE-HLS 7050 70100112

    Patients

    Seq Age Sex Outcome Treatment
    1