BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRISMAFLEX SYSTEM

    MDR report key: 970146 · Received August 18, 2006

    Report

    Report Number
    2087532-2006-00224
    Event Type
    Other
    Date Received
    August 18, 2006
    Date of Event
    July 19, 2006
    Report Date
    July 21, 2006
    Manufacturer
    GAMBRO LUNDIA AB, MONITOR DIV.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCIDENT WHERE THE PRISMAFLEX MACHINE PRODUCED AN INCORRECT PT FLUID REMOVAL DURING A ONE (1) HR I/O PERIOD, 1800-1900 IN 2006. THE SET PT FLUID REMOVAL RATE WAS 390 ML/H, THE ACTUAL PT FLUID REMOVED WAS 555ML. THERE WAS NO BLOOD LOSS REPORTED. REPORTED MACHINE RUNTIME WAS 353 (H).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM INTENSIVE CARE HEMODIALYSIS FII GAMBRO LUNDIA AB, MONITOR DIV. 6023014700 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other