BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 4000 SYRINGE INFUSION PUMP

    MDR report key: 18024852 · Received October 27, 2023

    Report

    Report Number
    3012307300-2023-09985
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    15019517069624
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED DAMAGE ON THE TOP CASE. EVENT HISTORY LOGS CONFIRMED MOTOR NOT RUNNING (MNR) MESSAGE. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED ISSUE WAS DUPLICATED; THE PUMP WENT INTO MNR DURING OCCLUSION TESTING. THE ROOT CAUSE OF THE ISSUE WAS THAT THE MAIN BOARD WAS OUT OF THE GROOVE ON THE EXTRUSION. TO CORRECT THE ISSUE, THE MAIN BOARD WAS REPOSITIONED BACK INTO THE GROOVE OF THE EXTRUSION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE EXHIBITED A MOTOR ERROR. 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
    1960071 MEDFUSION 4000 SYRINGE INFUSION PUMP PUMP, INFUSION FRN ST PAUL 4000 15019517069624

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown