BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 3172749 · Received June 3, 2013

    Report

    Report Number
    2183502-2013-00286
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 31, 2013
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING WAS ABLE TO REPRODUCE THE CUSTOMER'S COMPLAINT OF A "CHECK CLUTCH" ALARM. VISUAL INSPECTION REVEALED MISALIGNED CLUTCH HALVES. THE CLUTCH HALVES WERE REPLACED. AFTER REPAIR AND RECALIBRATION THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY, AND FUNCTIONAL TESTING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT STATED THE PUMP ALARMED "CHECK CLUTCH". NO PT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243870 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1