BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 PUMP

    MDR report key: 20802311 · Received November 27, 2024

    Report

    Report Number
    3012307300-2024-14200
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 1, 2024
    Report Date
    March 14, 2025
    Manufacturer
    SMITHS MEDICA ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Removal / Correction Number
    Z-1271-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H6: EVALUATION CODES UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A REVIEW OF THE EVENT HISTORY LOG FOUND EVIDENCE OF A PRIMARY AUDIBLE ALARM BGND TEST. DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED. THE CAUSE OF THE ISSUE WAS FOUND TO BE A FAULTY INTERCONNECT BOARD. THE INTERCONNECT BOARD WAS REPLACED. SERVICE HISTORY IDENTIFIED THAT NO PREVIOUS REPAIR HAS BEEN NOTED IN THE LAST 12 MONTHS.

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DEVICE'S PRIMARY AUDIBLE ALARM REPEATEDLY ALARMS AFTER GLUING J9 CONNECTOR. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED. D3: CORRECTION.

    Additional Manufacturer Narrative · 0

    H3: DEVICE NOT RECEIVED BY MANUFACTURER. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A PRIMARY AUDIBLE ALARM WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2611520 MEDFUSION 4000 PUMP PUMP, INFUSION FRN SMITHS MEDICA ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown