BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS COMBISET

    MDR report key: 3346710 · Received August 30, 2013

    Report

    Report Number
    8030665-2013-00572
    Event Type
    Death
    Date Received
    August 30, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 9, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN ADVERSE EVENT DURING TREATMENT WITH FRESENIUS PRODUCTS AND SUBSEQUENTLY EXPIRED. A SYSTEM LEVEL REVIEW IS BEING CONDUCTED FOR ALL CONCOMITANT PRODUCTS IN USE DURING TREATMENT. ADDITIONAL INFORMATION REGARDING THE EVENT, AS WELL AS MEDICAL RECORDS, WERE REQUESTED BUT HAVE BOT BEEN RECEIVED TO DATE. THE PLANT INVESTIGATION IS CURRENTLY ON-GOING. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ONCE THE PLANT INVESTIGATION AND CLINICAL INVESTIGATION ARE COMPLETE. PLEASE SEE RELATED MDR'S: 2937457-2013-000173, 1713747-2013-00353, 1713747-2013-99937, 3005162618-2013-00017, 3005162618-2013-00018.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT THE PT BECAME ILL DURING HEMODIALYSIS TREATMENT WHERE HE WAS TRANSPORTED TO THE HOSPITAL. THE PT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431187 FRESENIUS COMBISET FJK FRESENIUS MEDICAL CARE NORTH AMERICA COMBI SET

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R FRESENIUS NORMAL SALINE| FRESENIUS HEMODIALYSIS MACHINE| FRESENIUS DIALYZER| FRESENIUS COLLECTIVE CONCENTRATE - NATURALYTE