BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 19093159 · Received April 11, 2024

    Report

    Report Number
    3012307300-2024-02466
    Event Type
    Malfunction
    Date Received
    April 11, 2024
    Date of Event
    March 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO INFORMATION HAS BEEN PROVIDED TO DATE. ONE DEVICE WAS RECEIVED. NO PHYSICAL DAMAGE WAS NOTED. NO PROBLEM WAS FOUND DURING FUNCTIONAL TESTING. PERFORMED SOFTWARE DOWNLOAD 1.6.5 AND PERFORMED CALIBRATION, FUNCTIONAL AND FLOW DELIVERY TESTING. DEVICE PASSED ALL TESTING. THE PRODUCT'S HISTORY RECORDS WERE REVIEWED AND THERE WERE NO NON-CONFORMANCES NOR SERVICE-RELATED ISSUES THAT WOULD HAVE RESULTED IN THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF THE EVENT, IT WAS DETERMINED THAT THE REPORTED ISSUE DID NOT MEET THE CRITERIA FOR A COMPLAINT. NO DEFICIENCIES WERE ALLEGED REGARDING THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE OF THE DEVICE. PLEASE DISREGARD MRN 3012307300-2024-02466 AND ANY REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "MEDFUSION FIRMWARE REMEDIATION MARKET ACTION 240307-002436". THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333361 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown