BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 22048526 · Received May 19, 2025

    Report

    Report Number
    3012307300-2025-05838
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Date of Event
    February 1, 2025
    Report Date
    May 19, 2025
    Manufacturer
    SMITH¿S MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00054-00. THE DATE OF THAT SUBMISSION WAS 05-MAR-2025. H3: ONE PUMP WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED THE PUMP WAS IN USED CONDITION. SERVICE HISTORY IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING WAS PERFORMED. THE CAUSE OF THE REPORTED ISSUE WAS THE FLIPPERS WERE NOT OPENING FREELY AND THERE WERE SMALL CRACKS ON THE PLUNGER CASE. THE PLUNGER CASE ASSEMBLY WAS REPLACED TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166712 MEDFUSION 4000 PUMP PUMP, INFUSION FRN SMITH¿S MEDICAL ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown