BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 1327639 · Received February 27, 2009

    Report

    Report Number
    MW4004372
    Event Type
    Death
    Date Received
    February 27, 2009
    Date of Event
    January 21, 2009
    Manufacturer
    *
    Product Code
    FII
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    COMPLAINANT, SPOUSE OF DECEASED, REPORTS THE FOLLOWING: PT, FEMALE DIAGNOSED WITH RENAL FAILURE IN 2008. PHYSICIAN GAVE HER A GOOD PROGNOSIS. HOSPITALIZATION UNTIL FOLLOWING MONTH TO RECEIVE PORTS IN PREPARATION FOR IN-HOME DIALYSIS TREATMENT. RELEASED FROM THE HOSP, AND DEVICE WAS INSTALLED IN HOME ON OR ABOUT THAT SAME TIME. TREATMENT STARTED ON THE FOLLOWING DAY EVERY TUESDAY, THURSDAY AND SATURDAY. PT HAD RECEIVED 6 TREATMENTS WHILE HOSPITALIZED AND 21 AT RESIDENCE. HOME TREATMENTS WERE PROVIDED BY A NURSE. DEVICE INSTALLED IN HOME, AND APPEARS TO BE A 2-PART DEVICE. COMPLAINANT FEELS STRONGLY THAT THIS DEVICE IS RESPONSIBLE FOR THE UNTIMELY DEATH OF HIS SPOUSE. PHYSICIAN INFORMED COMPLAINANT THAT PT'S "BLOOD CONTAINED 12X MORE ACID THAN A NORMAL PERSON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * * FII * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death