BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE

    MDR report key: 1024247 · Received March 27, 2008

    Report

    Report Number
    6000001-2008-00197
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    January 5, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE LTD
    Product Code
    FRN
    PMA / PMN Number
    K915523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE PUMP BE RECEIVED FOR EVAL, A F/U REPORT WILL BE FILED UPON COMPLETION OF AN EVAL OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A MAUDE EVENT REPORT WAS RECEIVED BY BAXTER INDICATING THAT A FLO-GARD INFUSION PUMP REPORTEDLY OVER-INFUSED PROPOFOL DURING PT USE. THE PUMP WAS PROGRAMMED TO INFUSE A 100 CC BOTTLE OF PROPOFOL AT 19CC/HOUR, VOLUME TO BE INFUSED SET AT 90CC AT 2100. AT APPROX 2145, THE PUMP WAS ALARMING (UNK ALARM). THE NURSE CHECKED THE PT AND NOTED THE BOTTLE WAS EMPTY AND THAT THE ENTIRE AMOUNT OF PROPOFOL HAD INFUSED. "VOLUME TO BE INFUSED" ON THE PUMP READ 76CC. THE PUMP WAS REMOVED FROM SERVICE. NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FG 6301 DUAL CHNL VOL INF PUMP2M8064 SERVICE 80FRN FRN BAXTER HEALTHCARE PTE LTD

    Patients

    Seq Age Sex Outcome Treatment
    1