BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 20966981 · Received December 18, 2024

    Report

    Report Number
    3012307300-2024-15088
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    November 1, 2024
    Report Date
    March 20, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. THE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    E1: ADDRESS LINE 1 "2831 E PRESIDENT GEORGE BUSH HWY" 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS NOT CONSISTENTLY RECOGNIZING THE SYRINGE. PER REPORTER, THE DEVICE ONLY RECOGNIZES THE SYRINGE WHEN THE BARREL CLAMP IS POSITIONED AT AN ANGLE, WHICH IS NOT SUSTAINABLE FOR PROPER INFUSION. THERE WAS UNKNOWN PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2096598 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AMERITUS ENTERAL SYRINGE