BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS USA

    MDR report key: 489730 · Received September 26, 2003

    Report

    Report Number
    MW1029824
    Event Type
    Death
    Date Received
    September 26, 2003
    Date of Event
    September 2, 2003
    Report Date
    September 26, 2003
    Manufacturer
    FRESENIUS USA
    Product Code
    FII
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ON HEMODIALYSIS. NURSE FOUND TUBING DISCONNECTED FROM THE CATHETER, VISUAL ALARMS WERE DISPLAYED, AUDIBLE ALARMS WERE NOT SOUNDING. NURSE CALLED CODE, PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS USA HEMODIALYSIS MACHINE FII FRESENIUS USA A2008E *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death