BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS AMBULATORY INFUSION SYSTEM

    MDR report key: 17368094 · Received July 20, 2023

    Report

    Report Number
    3012307300-2023-07355
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Report Date
    September 15, 2023
    Manufacturer
    NULL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: B3. DATE OF EVENT IS UNKNOWN. D10. DEVICE AVAILABLE FOR EVALUATION, H3. DEVICE EVALUATED BY MANUFACTURER AND H6. EVALUATION CODES: UPDATED. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED. A VISUAL INSPECTION FOUND TAMPER SEALS REMOVED, DAMAGED FRONT AND REAR HOUSING AND A DAMAGED LENS. THE AC CONNECTOR, DOSE CONNECTOR, BACK-UP-CAPACITOR, DOWNSTREAM SENSOR AND USO SEAL WERE ALL CONTAMINATED BY FLUID INGRESSION. A REVIEW OF THE EVENT HISTORY LOG FOUND LEC 1140. DURING THE FUNCTIONAL TESTING, LEC 1140 AND LEC 1660 WERE FOUND ON THE DISPLAY. THE CAUSE OF THE ERRORS WAS FOUND TO BE THE FLUID DAMAGE ON THE MICROPROCESSOR BOARD. THE MICROPROCESSOR UNIT BOARD WAS REPLACED. 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., CORRECTED DATA: H6. HEALTH EFFECT CODES: UPDATED.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: 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 THAT THE PUMP HAD A LEC 1660. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2107520 CADD LEGACY PLUS AMBULATORY INFUSION SYSTEM PUMP, INFUSION FRN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown