BEUDAMED
    FDA Adverse Event Summary report: N

    GAMBRO

    MDR report key: 1022387 · Received March 13, 2008

    Report

    Report Number
    1022387
    Date Received
    March 13, 2008
    Date of Event
    January 31, 2008
    Report Date
    March 13, 2008
    Manufacturer
    GAMBRO RENAL PRODUCTS, INC.
    Product Code
    FII
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MACHINE PULLED OFF MORE WEIGHT THAN PRESCRIBED WHEN OPERATOR DID NOT FOLLOW PROPER PROCEDURE FOR MACHINE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO HEMODIALYSIS MACHINE FII GAMBRO RENAL PRODUCTS, INC. PHOENIX *

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR DIALYSIS| DIALYSIS