BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD LEGACY PLUS PUMP

    MDR report key: 22457740 · Received July 9, 2025

    Report

    Report Number
    3012307300-2025-08086
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 25, 2025
    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

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. 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.

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED FOR ANALYSIS OF COMPLAINT THAT THE PUMP HAD STOPPED. IT HAD ALARMED BUT HAD NOT IDENTIFIED THE SPECIFIC ALARM. NO EVENT HISTORY LOG PROVIDED. NO EVIDENCE PROVIDED FOR REVIEW. NO PREVIOUS REPAIR WAS NOTED FOR THE LAST 12 MONTHS. BASED ON THE REVIEW OF INFORMATION PROVIDED FROM THE CUSTOMER WE ARE UNABLE TO DETERMINE A PROBABLE CAUSE AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP HAD STOPPED. IT HAD ALARMED BUT HAD NOT IDENTIFIED THE SPECIFIC ALARM. THE PUMP SETTINGS HAD BEEN REVIEWED, AND THE INFUSION HAD BEEN RESTARTED. A "NO DISPOSABLE" ALARM HAD OCCURRED, WHICH HAD BEEN SILENCED, YET THE PUMP HAD CONTINUED BEEPING. THE PUMP HAD THEN BEEN POWERED DOWN. ACCORDING TO SFI, CASSETTES COULD NOT BE REMOVED. A PHONE NUMBER HAD BEEN PROVIDED PER SFI, AND THE PATIENT HAD BEEN INSTRUCTED TO CALL FOR FURTHER INSTRUCTIONS. THE RESERVOIR VOLUME HAD BEEN 13.2 ML, THE RATE HAD BEEN 2.0 ML/HR, AND THE VOLUME GIVEN HAD BEEN 78.80 ML. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT AT THE PATIENT'S HOME AND THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148549 CADD LEGACY PLUS PUMP PUMP, INFUSION FRN ICU MEDICAL, INC. 6500 10610586019647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown