BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 2843816 · Received October 25, 2012

    Report

    Report Number
    2183502-2012-00504
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    August 14, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS DAMAGED, WHICH CAUSED A CHECK CLUTCH/PLUNGER ALARM. THE POSITION POTENTIOMETER WAS REPLACED. FOLLOWING REPAIR, THE DEVICE PASSED ALL FUNCTION AND DELIVERY TESTING.

    Description of Event or Problem · 1

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

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1