BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY 1 PUMPS - 6400

    MDR report key: 17433240 · Received August 1, 2023

    Report

    Report Number
    3012307300-2023-07626
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION FOUND NO DAMAGE. A REVIEW OF THE EVENT HISTORY LOG FOUND LEC 1310. DURING THE FUNCTIONAL TESTING, LEC 1310 WAS DISPLAYED ON THE PUMP. THE CAUSE OF THE ERROR WAS FOUND TO BE USER ERROR AND THE LEC WAS CLEARED FROM THE PUMP. 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.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE IS SHOWING "LEC 1310". IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2335912 CADD LEGACY 1 PUMPS - 6400 PUMP, INFUSION FRN ST PAUL 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown