BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 19994285 · Received August 15, 2024

    Report

    Report Number
    3012307300-2024-07684
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 1, 2024
    Report Date
    September 24, 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

    E1: COVENANT HEALTH- GREY NUNS COMMUNITY HOSPITAL H3: 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.

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED AS A PRODUCT EVALUATION AND PROBLEM CONFIRMATION CANNOT BE PERFORMED. NO PREVIOUS REPAIR HAS BEEN NOTED IN THE LAST 12 MONTHS AND NO EVENT LOG HISTORY WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A RECURRING ERROR ¿SYRINGE FLANGE NOT IN PLACE". THE ALARM OCCURRED REPEATEDLY DESPITE THE PUMP CORRECTLY IDENTIFYING THE SYRINGE TYPE AND SIZE AT THE START OF THE INFUSION. THE AFFECTED DEVICE PASSED ALL THE DIAGNOSTIC TESTS, WHEN THE TEST SLUGS WERE USED, AND THE ERROR COULD NOT BE REPLICATED WITH STIMULATED INFUSION. PER REPORTER, ANOTHER NEOMED 6 ML SYRINGE BEING USED IN NICU WAS USED AND THEY DISCOVERED 2 PASSED WHILE 1 FAILED USING THE SYRINGE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895351 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown