BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRRT

    MDR report key: 1980401 · Received January 29, 2011

    Report

    Report Number
    1980401
    Event Type
    Malfunction
    Date Received
    January 29, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 29, 2011
    Manufacturer
    GAMBRO
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) FILTER SHOWED A MEMORY ERROR MESSAGE. THE FILTER WAS NOT FUNCTIONING, THE MD AND THE DIALYSIS RN WERE NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRRT CRRT KDI GAMBRO PRISMAFLEX *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR DIALYSIS