BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1230084 · Received November 17, 2008

    Report

    Report Number
    6000001-2007-88698
    Event Type
    Malfunction
    Date Received
    November 17, 2008
    Date of Event
    June 7, 2007
    Report Date
    June 11, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE HAS NOT YET BEEN RECEIVED EVALUATION. SHOULD THE PUMP BE 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, "MEDICATION WAS SET FOR 10 CC. AND WHEN THE NURSE LOOK IT STARTED AT 50 CC OR MORE. THEY WERE GOING TO START ADMINISTRATING THE MEDICATION TO THE PATIENT AT 10 CC AND SUDDENLY THE MACHINE STARTED AT 50 CC OR MORE. MACHINE WAS REMOVED FROM THE PATIENT." THE HOSPITAL REPRESENTATIVE STATED THAT THERE WERE NO REPORTS OF 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 N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1