BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX

    MDR report key: 1595824 · Received January 16, 2010

    Report

    Report Number
    1595824
    Event Type
    Malfunction
    Date Received
    January 16, 2010
    Date of Event
    December 16, 2009
    Report Date
    January 15, 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

    THE DIALYSATE BAG WAS CHANGED AND FIVE MINUTES LATER THERE WAS AN EXCESS FLUID LOSS/GAIN ALARM SOUND. NO ALARMS BETWEEN BAG CHANGE AND THE EXCESS FLUID LOSS GAIN. THERE WAS NO CHANCE TO TROUBLESHOOT. THE FILTER HAD TO BE TAKEN DOWN AND A NEW ONE PUT UP. THE DATA CARD WAS DOWNLOADED AND THE SYSTEM WAS RESTARTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR DIALYSIS