BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 1812692 · Received August 18, 2010

    Report

    Report Number
    2183502-2010-00360
    Event Type
    Malfunction
    Date Received
    August 18, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 8, 2010
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. (B)(4)

    Description of Event or Problem · 1

    TITLE: XXXXX. EVENT DESC: ERROR MESSAGE AFTER INFUSION STARTED ON PRECEDEX: "CHECK PLUNGER" X 6 AND INFUSION STOPPAGE EACH TIME. PUMP SWITCHED OUT AND RUNNING APPROPRIATELY NOW. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR