BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION® 3500 SYRINGE PUMP

    MDR report key: 6027711 · Received October 13, 2016

    Report

    Report Number
    3012307300-2016-00087
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    September 16, 2016
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED MEDFUSION® SYRINGE PUMP WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION FOUND THE DEVICE TO BE IN POOR CONDITION. THE DEVICE TAMPER STICKER WAS VOID AND THE TOP CASE WAS CHIPPED AND CRACKED. ADDITIONALLY, THE RIGHT PLUNGER CASE WAS FOUND CRACKED. A REVIEW OF THE DEVICE EVENT HISTORY LOG FOUND THAT A MOTOR RATE ERROR, CHECK CLUTCH ERROR, AND PRESSURE INCREASING ALARM HAD OCCURRED. DURING FUNCTIONAL FLOW TESTING, THE DEVICE GAVE A MOTOR RATE ERROR. TESTING WAS UNABLE TO CONFIRM THE CHECK CLUTCH ERROR AS THE PUMP WOULD GO INTO THE MOTOR RATE ERROR DURING TESTING. INVESTIGATION DETERMINED THE CAUSE OF THE MOTOR RATE ERROR TO BE THE IMPROPER SEATING OF THE MAIN BOARD ONTO THE EXTRUSION. BASED UPON A REVIEW OF THE DEVICE EVENT HISTORY LOG, IT WAS DETERMINED THAT THE CHECK CLUTCH ERROR WAS CAUSED BY THE CLUTCH BEING RELEASED DURING AN INFUSION. THE PRESSURE INCREASE WAS FOUND TO BE A PART OF THE DEVICE'S NORMAL OPERATION. AFTER DEVICE REPAIR AND RECALIBRATION, THE DEVICE WAS FOUND TO PASS ALL DELIVERY, ACCURACY AND FUNCTIONAL TESTS.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY BEING EVALUATED; THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION ONCE IT IS COMPLETED. MFR# CLARIFICATION: NEW REGISTRATION NUMBER (B)(4) IS NOW BEING USED FOR MFR REPORT NUMBER, REPLACING REGISTRATION NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MEDFUSION PUMP ENCOUNTERED A CHECK CLUTCH ERROR. NO ADVERSE HEALTH OUTCOMES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679687 MEDFUSION® 3500 SYRINGE PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1