BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PCA AMBULATORY INFUSION SYSTEM

    MDR report key: 17494838 · Received August 9, 2023

    Report

    Report Number
    3012307300-2023-07992
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Report Date
    October 26, 2023
    Manufacturer
    ST PAUL
    Product Code
    MEA
    UDI-DI
    10610586019449
    PMA / PMN Number
    K982839
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    EVALUATION CODES: UPDATED DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR INVESTIGATION. TAMPER SEALS WERE NOT BROKEN OR REMOVED. VISUAL INSPECTION NOTED NO DAMAGE TO THE DEVICE. REVIEW OF THE ERROR HISTORY LOG FOUND "LEC 1310" MESSAGE ON THE PUMP DISPLAY. FUNCTIONAL TESTING DUPLICATED THE "LEC 1310 ERROR" ISSUE DURING THE INVESTIGATION. LEC 1310 WAS USER ERROR AND DEVICE USED IMPROPERLY CAUSE MESSAGE DISPLAYED ERROR CODE. RECOMMENDED LEC 1310 TO BE CLEARED ERROR CODE. ROOT CAUSE WAS ATTRIBUTED TO USER ERROR AND THE DEVICE BEING USED IMPROPERLY CAUSED THE ERROR MESSAGE. 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. CLEARED THE ERROR CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP DISPLAYED AN ERROR CODE. PATIENT INVOLVEMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1684563 CADD LEGACY PCA AMBULATORY INFUSION SYSTEM PUMP, INFUSION, PCA MEA ST PAUL 6300 10610586019449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown