BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1051953 · Received May 22, 2008

    Report

    Report Number
    6000001-2008-00331
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 25, 2008
    Report Date
    May 8, 2008
    Manufacturer
    BAXTER HEALTHCARE (SG)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION, HOWEVER, EVALUATION IS NOT COMPLETE. 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'S BIOMEDICAL TECHNICIAN REPORTED THAT THE PUMP'S FREE FLOW PROTECTION MALFUNCTIONED WHEN USERS TURNED OFF THE PUMP. IT IS UNKNOWN IF THERE WAS INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE (SG) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1