BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMBRO RENAL PRODUCTS

    MDR report key: 438437 · Received January 10, 2003

    Report

    Report Number
    MW1027247
    Event Type
    Malfunction
    Date Received
    January 10, 2003
    Date of Event
    December 13, 2002
    Report Date
    January 10, 2003
    Manufacturer
    CGH MEDICAL INC.
    Product Code
    FII
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    GAMBRO RENAL PRODUCTS HAD PREVIOUSLY REPORTED ELECTROSTATIC ECG ARTIFACT WITH THE PRISMA MODEL DIALYSIS MACHINE. FACILITY HAS EXPERIENCED 3 SEPARATE INCIDENTS OF THIS TYPE WHILE PATIENTS WERE BEING MONITORED WITH THE ZOLL DEFIBRILLATOR. GAMBRO WAS CONTACTED AND VERIFIED THE PROBLEMS WITH THE PRISMA MODEL BUT HAD NOT RECEIVED COMPLAINTS WITH THE C-3 MODEL. THE CONCERN IS ACTIONS/SOLUTIONS RECOMMENDED BY GAMBRO -WET TUBING WITH RO WATER, LABEL ON MACHINE AND ADDENDUM IN OPERATORS MANUAL- MAY NOT BE SATISFACTORY. OTHER CONCERNS RELATE TO UNK EFFECTS ON OTHER CRITICAL PIECES OF EQUIPMENT -I.E. BYPASS MACHINE- AS THE EQUIPMENT IS USED IN VARIOUS AREAS OF THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMBRO RENAL PRODUCTS GAMBRO C-3 DIALYSIS MACHINE FII CGH MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other