BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 20290880 · Received September 24, 2024

    Report

    Report Number
    3012307300-2024-09799
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 1, 2024
    Report Date
    November 6, 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

    ONE DEVICE WAS RETURNED FOR REPAIR. ALARM HISTORY REVIEWED AND WAS UNABLE TO FIND ERROR MESSAGE. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. THE EVENT HISTORY LOG WAS REVIEWED. VISUAL AND FUNCTIONAL TESTS WERE PERFORMED. WHEN BOOTING THE PUMP, IT WAS NOT ABLE TO BOOT. PROBABLE CAUSE OF REPORTED PROBLEM WAS BAD MAIN PRINTED CIRCUIT BOARD (PCB) AND INTERCONNECT BOARD. THE INTERCONNECT WAS CORRODED FROM LIQUID DAMAGE AND THE MAIN BOARD DID NOT ALLOW FOR LEARNING OF CONFIGURATION LIBRARIES. AFTER ALL PARTS WERE REPLACED, THE PUMP WAS VALIDATED AND WAS IN PROPER WORKING ORDER.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869451 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown