BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 381420 · Received March 6, 2002

    Report

    Report Number
    2937457-2002-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Date of Event
    February 13, 2002
    Report Date
    February 14, 2002
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FIL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRESENIUS MEDICAL CARE CANADA, INC. REPORTED THAT THERE WAS EXCESS FLUID REMOVED FROM A PATIENT DURING A HEMODIALYSIS TREATMENT. THE PATIENT WAS ASYMPTOMATIC BUT BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOTED TO BE SLIGHTLY DARK. VENOUS PRESSURE WAS FLUCTUATING BETWEEN 220 TO 400 WITH TRANSMEMBRANE PRESSURE 180-260. THE PATIENT WAS WEIGHED AT THIS TIME AND BASED ON WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT AT THIS TIME AND BASED ON WHAT THE MACHINE INDICATED WAS REMOVED, THERE WAS A WEIGHT LOSS VARIANCE OF APPROXIMATELY 1.3 KG. TREATMENT WAS CONTINUED ON ANOTHER MACHINE WITH NO FURTHER PROBLEM. 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 UNKNOWN