BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROUND DUAL LUMEN PLASMAPHERESIS CATHETER/HEMODIALYSIS

    MDR report key: 20467 · Received February 16, 1995

    Report

    Report Number
    20467
    Event Type
    Death
    Date Received
    February 16, 1995
    Date of Event
    February 3, 1995
    Report Date
    February 16, 1995
    Manufacturer
    DAVOL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SURGERY FOR PLACEMENT OF VENOUS ACCESS CATHETER INTO THE SUPERIOR VENA CAVA VIA THE SUBCLAVIAN USING A ROUND DUAL LUMEN HEMODIALYSIS/PLASMAPHERESIS CATHETER AND PERCUTANEOUS INTRODUCER KIT WITH TUNNELER. SURGERY COMPLETED 9:00. CODE CALLED 9:15. PT PRONOUNCED EXPIRED 9:53.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROUND DUAL LUMEN PLASMAPHERESIS CATHETER/HEMODIALYSIS 13.5 FR 40 CM ROUND DUAL LUMEN PLASMAPHERESIS CATHETER/HEMOS DQO DAVOL, INC. 36JE2759

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death