BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY PLUS

    MDR report key: 21315296 · Received February 5, 2025

    Report

    Report Number
    3012307300-2025-01531
    Event Type
    Malfunction
    Date Received
    February 5, 2025
    Date of Event
    January 10, 2025
    Report Date
    April 17, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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

    D3: CORRECTION. H3: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. SERVICE HISTORY IDENTIFIED THAT NO PREVIOUS REPAIR HAS BEEN NOTED IN THE LAST 12 MONTHS. THE EVENT HISTORY LOG WAS NOT PROVIDED. AS THE PRODUCT WAS NOT RETURNED, AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO AID IN THIS INVESTIGATION, A PRODUCT EVALUATION AND PROBLEM CONFIRMATION CANNOT BE PERFORMED. THEREFORE, THIS INVESTIGATION WAS UNABLE TO DETERMINE A PROBABLE CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS ALARMING NO DISPOSABLE PUMP WILL NOT RUN. SETTINGS REVIEWED, PUMP TURNED OFF AND TUBING CLAMPED. DUE TO SFI, THEY CANNOT DISMANTLE THE PUMP TO FURTHER TROUBLESHOOT. PATIENT NOT CURRENTLY AFFECTED. THIS EVENT OCCURRED AT PATIENT'S HOME AND WAS OPERATED BY A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135207 CADD-LEGACY PLUS PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown