BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1051952 · Received May 22, 2008

    Report

    Report Number
    6000001-2008-00337
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 9, 2008
    Manufacturer
    SO SINGAPORE HDW PLANT - US (REL).
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION. WHEN THE PUMP IS RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED "EQUIPMENT IS EXTINGUISHED - EQUIPO SE APAGA" ON A FLOGARD PUMP. INFORMATION WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PATIENT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFORMATION, DETAILS WERE NOT AVAILABLE REGARDING ADDITIONAL CONTACT INFORMATION. ACCORDING TO THE FACILITY REPRESENTATIVE, NO PATIENT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN SO SINGAPORE HDW PLANT - US (REL). NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1