BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    MDR report key: 1031666 · Received April 18, 2008

    Report

    Report Number
    6000001-2008-00258
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 24, 2008
    Manufacturer
    SO SINGAPORE HDW PLANT - US (REL)
    Product Code
    FRN
    PMA / PMN Number
    K915522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVAL, HOWEVER, EVAL IS NOT COMPLETE. A F/U REPORT WILL BE FILED UPON COMPLETION OF THE EVAL OR IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REP REPORTED "KEEPS STOPPING". INFO WAS NOT PROVIDED REGARDING WHETHER OR NOT THE PROBLEM OCCURRED DURING A PT INFUSION. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN INFO, DETAILS WERE NOT AVAILABLE REGARDING ADD'L CONTACT INFO. ACCORDING TO THE FACILITY REP, NO PT INJURY OR MEDICAL INTERVENTION HAD BEEN REPORTED RELATED TO THE DEVICE. NO ADD'L INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLO-GARD 6201 VOLUMETRIC INFUSION PUMP 80FRN FRN SO SINGAPORE HDW PLANT - US (REL) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1