BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 9682783 · Received February 7, 2020

    Report

    Report Number
    3012307300-2020-00802
    Event Type
    Malfunction
    Date Received
    February 7, 2020
    Report Date
    February 7, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: ONE SMITHS MEDICAL MEDFUSION 4000 SYRINGE INFUSION PUMP WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION SHOWED THE PUMP WAS IN GOOD CONDITION WITH NO APPEARANCE OF ANY PHYSICAL DAMAGE. THE TAMPER SEAL ON THE BOTTOM CASE WAS BROKEN/REMOVED. FUNCTIONAL TESTING INVOLVED VISUAL INSPECTION OF THE INTERCONNECT BOARD AND SHOWED A CABLE CONNECTOR ON THE INTERCONNECT BOARD WAS MISSING AND THE CONNECTOR ON THE INTERCONNECT BOARD WAS BADLY DAMAGED. ACCORDING TO THE INVESTIGATION, THIS ISSUE WAS A RESULT OF THE CUSTOMER'S PHYSICAL DAMAGE TO THE DEVICE DURING THEIR PUMP REPAIR PROCESS. THE INTERCONNECT, MAIN PRINTED CIRCUIT BOARD AND POWER SUPPLY WERE REPLACED AS WELL AS THE LCD DISPLAY DUE TO A MISSING PIXEL. BEYOND DEVICE REPAIR, NO FURTHER ACTION WILL BE TAKEN ON THIS ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE INTERCONNECT BOARD WAS BROKEN ON A SMITHS MEDICAL MEDFUSION 4000 SYRINGE INFUSION PUMP. IT WAS REPORTED THAT THE CONNECTOR ON THE RIBBON WAS BROKEN. NO ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146325 MEDFUSION 4000 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1