BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 407798 · Received July 24, 2002

    Report

    Report Number
    2937457-2002-00036
    Event Type
    Malfunction
    Date Received
    July 24, 2002
    Date of Event
    June 21, 2002
    Report Date
    June 27, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FIL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT ULTRAFILTRATION (UF) RATE WAS HIGHER THAN EXPECTED DURING THE FIRST 2 1/2 HRS. OF A HEMODIALYSIS TREATMENT. GOAL WAS SET FOR 3 1/2 HRS. BUT WAS REACHED IN 2 1/2 HRS. TREATMENT WAS COMPLETED WITH THE UF OFF. THERE WAS NO SERIOUS INJURY OR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRESENIUS DIALYSIS DELIVERY SYSTEM HEMODIALYSIS MACHINE FIL FRESENIUS MEDICAL CARE NORTH AMERICA 2008K NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR