BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 24638762 · Received March 19, 2026

    Report

    Report Number
    3012307300-2026-02699
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 5, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    UDI-DI
    10610586019647
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: NO DEVICE OR DEVICE PHOTO WAS RETURNED FOR INVESTIGATION. DUE TO THIS, NO ROOT CAUSE WAS DETERMINED AS A PRODUCT EVALUATION AND PROBLEM CONFIRMATION CANNOT BE PERFORMED. NO PREVIOUS REPAIR HAS BEEN NOTED IN THE LAST 12 MONTHS, AND NO EVENT LOG HISTORY WAS PROVIDED. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    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. ADDITIONAL CONTACT INFORMATION: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT CALLED WITH PUMP ALARMING ND. THE ALARM WAS SILENCED AND SETTINGS REVIEWED. RES VOL 11.7ML, RATE 2.0ML PER HR, VOLUME GIVEN 80.3ML. THE PUMP WAS RESTARTED AND THE ALARM RETURNED. THE PUMP WAS POWERED DOWN. PER SFI, CASSETTES ARE NOT TO BE REMOVED- NO FURTHER TROUBLESHOOTING WAS DONE. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252141 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown