BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 22035203 · Received May 16, 2025

    Report

    Report Number
    3012307300-2025-05792
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    February 1, 2025
    Report Date
    May 16, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 2183161-2025-00053. THE DATE OF THAT SUBMISSION WAS 25-MAR-2025. ONE DEVICE WAS RECEIVED FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED AND FUNCTIONALLY TESTED. COMPLAINT CONFIRMED BY CHECKING THE ALARM HISTORY. DEVICE IS REPAIR BY REPLACING THE SPEAKER. THE DEVICE PASSED ALL FUNCTIONAL TESTS AFTER REPAIR. SERVICE HISTORY REVIEW IDENTIFIED THERE WAS NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD A PRIMARY AUDIBLE ALARM BGND TEST ERROR DURING THE INFUSION. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909264 MEDFUSION 4000 PUMP PUMP, INFUSION FRN SMITH¿S MEDICAL ASD, INC. 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown