BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 2000009 · Received February 17, 2011

    Report

    Report Number
    2183502-2011-00041
    Event Type
    Malfunction
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 15, 2011
    Manufacturer
    SMITHS MEDICAL MD
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. TESTING INDICATED THAT THE POSITION POTENTIOMETER WAS NON-FUNCTIONAL. THE POSITION POTENTIOMETER WAS REPLACED. AFTER REPAIR, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTS.

    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
    1 MEDFUSION 3500 SYRINGE INFUSION PUMP SYRINGE INFUSION PUMP FRN SMITHS MEDICAL MD 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE