BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    MDR report key: 4161837 · Received July 24, 2014

    Report

    Report Number
    2183502-2014-00517
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    SMITHS MEDICAL
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER COMPLETED THE ENTIRE FORM. ADDITIONAL MANUFACTURER NARRATIVE: THE SUSPECT DEVICE WAS RETURNED AND EVALUATED. A REVIEW OF THE EVENT HISTORY LOG CONFIRMED THE ERROR HAD OCCURRED. THE ERROR WAS DUPLICATED THROUGH TESTING. DURING VISUAL INSPECTION WORN CLUTCH HALVES WERE IDENTIFIED. THE CLUTCH HALVES WERE REPLACED. AFTER REPAIR AND RECALIBRATION 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 PATIENT INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433100 MEDFUSION 3500 SYRINGE INFUSION PUMP FRN-SYRINGE INFUSION PUMP FRN SMITHS MEDICAL 3500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK