BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 25162498 · Received May 13, 2026

    Report

    Report Number
    3012307300-2026-04948
    Event Type
    Malfunction
    Date Received
    May 13, 2026
    Date of Event
    April 21, 2026
    Report Date
    May 13, 2026
    Manufacturer
    ICU MEDICAL, 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

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP ALARMED FOR NO DISPOSABLE (ND) ALARM. THE ALARM WAS SILENCED AND THE INFUSION WAS RESTARTED, BUT THE PUMP WAS RUNNING WITH A DOUBLE BEEP PRESENT. THEN THE ND ALARM RETURNED. THEN CASSETTE WAS REMOVED, TUBING WAS MASSAGED, AND CASSETTE WAS TAPED ON A HARD SURFACE AND REATTACHED. HOWEVER, THE ND ALARM PERSISTED. THE EVENT OCCURRED DURING INFUSION, WITH PATIENT INVOLVEMENT AND NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86361 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown