BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR PUMP

    MDR report key: 1243205 · Received November 10, 2008

    Report

    Report Number
    6000001-2008-00738
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 21, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FRN
    PMA / PMN Number
    K926385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A PUMP THAT IS "NOT GIVING THE CORRECT BOLUS, OVERINFUSION". THIS WAS FOUND DURING PT USE, WITH NO PT INJURY REPORTED. ALTHOUGH BAXTER ATTEMPTED TO OBTAIN ADDITIONAL INFO NON WAS AVAILABLE AT THE TIME OF THIS REPORT. NO ADDITIONAL DETAILS WERE AVAILABLE REGARDING ADDITIONAL CONTACT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP 80FRN FRN BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1