BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD-LEGACY INFUSION PUMP

    MDR report key: 20737412 · Received November 20, 2024

    Report

    Report Number
    3012307300-2024-13661
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 24, 2024
    Report Date
    February 12, 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

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    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 REPORTABLE INFORMATION BECOMES AVAILABLE

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE HAD AN UPSTREAM OCCLUSION ALARM. IT HAD BEEN CONFIRMED THAT THERE WERE NO OBVIOUS OCCLUSIONS BETWEEN THE PUMP AND THE MEDICATION BAG, AND THAT THE MEDICATION BAG WAS FULLY SPIKED. THE CASSETTE COULD NOT BE REMOVED, AS PER SFI. THE DEVICE IS NOT AVAILABLE FOR EVALUATION/RETURN. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433202 CADD-LEGACY INFUSION PUMP PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown