BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO

    MDR report key: 298532 · Received September 27, 2000

    Report

    Report Number
    MW1020036
    Event Type
    Malfunction
    Date Received
    September 27, 2000
    Date of Event
    September 22, 2000
    Report Date
    September 27, 2000
    Manufacturer
    GAMBRO, INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AT COMPLETION OF DIALYSIS, RN DISCOVERED MACHINE REMOVED 3.5 KG FROM PT INSTEAD OF 1.5 KG AS PROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO DIALYSIS CS3 UF FII GAMBRO, INC. 333900001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other