BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 666211 · Received January 12, 2006

    Report

    Report Number
    MW1037723
    Event Type
    Death
    Date Received
    January 12, 2006
    Date of Event
    December 17, 2005
    Report Date
    January 12, 2006
    Manufacturer
    GAMBRO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT STARTED USING THE DIALYZER 18 MONTHS AGO. AT 10:10PM. THE DECEASED CALLED HER SON AND REPORTED THAT THE MACHINE WOULD NOT STEP OUT OF DRAIN 1. AFTER A WHILE THE MACHINE WAS ABLE TO STEP OUT OF DRAIN 1. BY 1:15 AM THE PT PASSED AWAY. MACHINE WAS IN DRAIN 3 OF 5. AT THE TIME IT DISPLAYED 7 ML. NO DRAIN READINGS. ULTRAFILTRATION WAS SHOWN ON THE SCREEN AS 1660 ML. PT SUSPECTED TO HAVE DIED OF CHF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * HOME CHOICE DIALYSIS DEVICE FKX GAMBRO * *

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death