BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 17777728 · Received September 19, 2023

    Report

    Report Number
    3012307300-2023-09090
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Report Date
    November 3, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION NOTED NO EXTERIOR DAMAGE. REVIEW OF THE ERROR HISTORY LOG FOUND NO ALARMS PERTAINING TO THE CUSTOMER'S REPORTED PROBLEM. FUNCTIONAL TESTING WAS UNABLE TO DUPLICATE CUSTOMER'S REPORTED PROBLEM. CALIBRATIONS WERE FOUND WITHIN SPECIFICATION. NO ROOT CAUSE COULD BE DETERMINED AS THE COMPLAINT WAS NOT CONFIRMED. 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. REPLACED INTERCONNECT BOARD DUE TO BROKEN OFF "C13". INSTALLED MISSING IPX-PSA SHIELD AND ESD PLATE. CLEANED, GREASED AND CALIBRATED THE PUMP AND PERFORMED ALL TEST WHICH PASSED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP EXHIBITED A "FORCE SENSOR FAILURE." IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85274 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown