BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 1595427 · Received January 18, 2010

    Report

    Report Number
    1595427
    Event Type
    Malfunction
    Date Received
    January 18, 2010
    Date of Event
    December 21, 2009
    Report Date
    January 18, 2010
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC
    Product Code
    MQS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHILE RUNNING THE CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY MACHINE), IT STOPPED AND GAVE AN ERROR CODE 6. UNABLE TO RUN MACHINE. MESSAGE ERROR WAS RELATED TO SOMETHING ABOUT OVER LIMIT OF 780 CC. THE DATA WAS DOWNLOADED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX HEMODIALYSIS MACHINE, CONTINUOUS RENAL REPLACEMENT THERAPY MQS GAMBRO RENAL PRODUCTS, INC * N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR