BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENOUS BLOODLINE FOR FRESENIUS 2008

    MDR report key: 405067 · Received July 12, 2002

    Report

    Report Number
    8030665-2002-00051
    Event Type
    Death
    Date Received
    July 12, 2002
    Date of Event
    July 6, 2002
    Report Date
    July 12, 2002
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY REPORTS THAT ONE HOUR INTO THE TREATMENT THE PT SAT UP CAUSING THE VENOUS BLOODLINE TO DISCONNECT FROM THE PT'S ASH SPLIT CATHETER. HEMODIALYSIS MACHINE IMMEDIATELY ALARMED. BLOOD NOTED ON FLOOR AND PT, ESTIMATED AMOUNT COULD NOT BE DETERMINED. THE PT THEN WENT INTO CARDIAC ARREST, BLS PROCEDURES INITIATED AND THE PT WAS TRANSFERRED TO HOSPITAL E.R. AND COULD NOT BE REVIVED. VENOUS BLOOD LINE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENOUS BLOODLINE FOR FRESENIUS 2008 HEMODIALYSIS DEVICE FKJ REYNOSA MANUFACTURING NA 2DR111

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death ASH SPLIT CATHETER.