BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION 3500 PUMP

    MDR report key: 17786036 · Received September 20, 2023

    Report

    Report Number
    3012307300-2023-09184
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Report Date
    November 17, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586032318
    PMA / PMN Number
    K040899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE DEVICE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED A NON-OEM BATTERY, A NON-OEM BOTTOM CASE, AND THE TOP AND BOTTOM CASES SLIGHTLY SEPARATED IN THE FRONT LEFT CORNER. REVIEW OF THE EVENT HISTORY LOGS SHOWED MESSAGES FOR MOTOR NOT RUNNING (MNR), MOTOR RATE ERROR (MRE), AND INVALID SYRINGE SIZE. FUNCTIONAL TESTING WAS PERFORMED; THE MNR AND MRE ISSUES WERE NOT ABLE TO BE REPLICATED BUT THE PUMP WENT INTO INVALID SYRINGE SIZE DURING OCCLUSION TESTING. THE ROOT CAUSE OF THE ISSUE WAS DETERMINED TO BE FOREIGN MATERIAL FOUND ON AND AROUND THE U29 ON THE MAIN BOARD AND EXCESSIVE GREASE ON THE WORM COUPLING AND WORM GEAR. THE U29 ON THE MAIN BOARD WAS CLEANED, THE WORM COUPLING AND WORM GEAR WERE REPLACED, AND THE SIZE POT WAS REPLACED. SERVICE HISTORY REVIEW IDENTIFIED NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Additional Manufacturer Narrative · 0

    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 "MOTOR NOT RUNNING," "MOTOR RATE ERROR" AND "INVALID SYRINGE SIZE" ALARM MESSAGES. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1519424 MEDFUSION 3500 PUMP PUMP, INFUSION FRN ST PAUL 3500 10610586032318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown