BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 20290682 · Received September 24, 2024

    Report

    Report Number
    3012307300-2024-09797
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 12, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H3, H6: THE DEVICE WAS RETURNED FOR ROOT CAUSE ANALYSIS AND THE INVESTIGATION FINDINGS CONCLUDED AFTER VISUAL INSPECTION, FUNCTIONAL TESTING, AND EVENT HISTORY LOG (EHL) REVIEW, THE CUSTOMER PROBLEM WAS DUPLICATED. THE PUMP WAS FOUND TO HAVE A A2D REFERENCE VOLTAGE BGND TEST ERROR SHOWN IN THE EHL AND DURING START-UP TEST. THE CAUSE OF THE CUSTOMER REPORTED PROBLEM WAS A MAIN BOARD ERROR. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE MANUFACTURER REPRESENTATIVE REPLACED THE MAIN BOARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHOWED SYSTEM FAULT - D TO A OFFSET VOLTAGE- B TO GROUND TEST FAILURE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/UNKNOWN ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015934 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown