BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 PUMP

    MDR report key: 20559393 · Received October 29, 2024

    Report

    Report Number
    3012307300-2024-12299
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 27, 2024
    Report Date
    January 27, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE FILE IT WAS DETERMINED THAT IT WAS A DUPLICATE OF AN EXISTING COMPLAINT RECORD. PLEASE DISREGARD ANY REPORTS ASSOCIATED WITH FILE MRN. PLEASE REFERENCE FILE MRN 3012307300-2024-12301-00 FOR ALL DETAILS PERTINENT TO THIS EVENT.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WAS GIVING MOTOR RATE ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320378 MEDFUSION 3500 PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 3500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown