BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 1594040 · Received January 24, 2010

    Report

    Report Number
    1594040
    Event Type
    Malfunction
    Date Received
    January 24, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 19, 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

    CRRT (CONTINUOUS RENAL REPLACMENT THERAPY) MACHINE ALARMED GENERAL SYSTEM FAILURE. THE HISTORY WAS DOWNLOADED AND A NEW MACHINE WAS PRIMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX SYSTEM, HEMODIALYSIS, ACCESS RECIRCULATION MONITORING MQS GAMBRO RENAL PRODUCTS, INC PRISMAFLEX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR