BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 21194219 · Received January 20, 2025

    Report

    Report Number
    3012307300-2025-00977
    Event Type
    Malfunction
    Date Received
    January 20, 2025
    Date of Event
    December 1, 2024
    Report Date
    April 15, 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
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    CORRECTED: D3 MANUFACTURING PLANT ADDRESS, STATE, AND ZIP CODE. G4: PMA/510(K) #; K982836. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. THE SERVICE HISTORY REVIEW HAD NO INDICATION THAT THE COMPLAINT WAS RELATED TO A SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE IS EXPERIENCING A HIGH PRESSURE ALARM AND NEED SUPPORT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555527 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown