BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 371748 · Received January 11, 2002

    Report

    Report Number
    2937457-2002-00007
    Event Type
    Malfunction
    Date Received
    January 11, 2002
    Date of Event
    December 19, 2001
    Report Date
    January 3, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE-NORTH AMERICA
    Product Code
    FIL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORTS OF ULTRAFILTRATION PROBLEMS THAT WERE OBSERVED OVER SEVERAL MONTHS WERE RECEIVED FROM THE MANUFACTURER'S AFFILIATE IN CANADA ON 12/14/2001 AND ON 01/03/2002. REPORTS SUGGEST EXCESS FLUID WAS REMOVED DURING HEMODIALYSIS TREATMENTS. INFORMATION PROVIDED WAS VERY LIMITED. THERE WAS NO REPORTED SERIOUS INJURY. THE PATIENT BECAME HYPOTENSIVE 27 MINUTES INTO THE TREATMENT. "BLACK BLOOD" WAS REPORTEDLY OBSERVED. THE PATIENT'S POST WEIGHT INDICATED A WEIGHT LOSS OF 1.7 KG. THE MACHINE SHOWED THAT 397 ML. WAS REMOVED. PRESSURE HOLDING TEST WAS NOT PERFORMED AND ON-LINE PRESSURE HOLDING TEST WAS NOT ACTIVATED.

    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 UNKNOWN