BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 3192422 · Received June 19, 2013

    Report

    Report Number
    2183502-2013-00328
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 18, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER NON-FUNCTIONAL DUE TO A BROKEN TAB. THE POSITION POTENTIOMETER WAS REPLACED. FOLLOWING REPLACEMENT, THE DEVICE PASSED ALL FUNCTION AND DELIVERY TESTING.

    Description of Event or Problem · 1

    A REPORT WAS REC'D 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
    278570 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD, INC. 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1