BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24512458 · Received March 4, 2026

    Report

    Report Number
    3012307300-2026-02001
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    November 1, 2025
    Report Date
    March 4, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K982836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODES WERE UPDATED. TWO DEVICE WAS RETURNED FOR INVESTIGATION. THE COMPLAINT OF OCCLUSION CAN BE CONFIRMED ON ONE OF THE TWO SETS. VISUAL AND FUNCTIONAL TESTING WAS PERFORMED. AN OCCLUSION TEST WAS CONDUCTED ON THE RETURNED SAMPLE PER MANUFACTURING SPECIFICATIONS. FLOW WAS ESTABLISHED ON SAMPLE 1. AN OCCLUSION WAS OBSERVED IN SAMPLE 2. IN ATTEMPTS TO LOCATE THE OCCLUSION THE FEMALE LUER WAS CUT OFF THE SET AND THE TEST WAS REPEATED USING A CANULA PROVIDED BY ICU MEDICAL. THE OCCLUSION REMAINED. IN ATTEMPTS TO BETTER VISUALIZE THE OCCLUSION RED DYE WAS PUSHED INTO THE TUBING USING A SYRINGE AND A CANULA PROVIDED BY ICU MEDICAL. THE PROBABLE CAUSE IS UNKNOWN AS THE OCCLUSION WAS CLEARED DURING TESTING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PWD EXPERIENCED A LINE BLOCKED ALARM WHILE USING A NON-ICUMED DEVICE. PRIOR TO CONTACTING PSS, THE PWD ATTEMPTED TO RESOLVE THE ISSUE BY USING THE CURRENT CASSETTE AND INFUSION SET, BUT THE ALARM PERSISTED. THE PWD THEN REPLACED ONLY THE CANNULA PORTION OF THE INFUSION SET AND RESUMED USE WITH THE SAME CASSETTE, DELIVERING AN APPROXIMATE 6U BOLUS SUCCESSFULLY; HOWEVER, THE ALARM RECURRED AFTERWARD. AT THAT POINT, THE PWD CONTACTED PSS. THE CURRENT CASSETTE WAS APPROXIMATELY 4 DAYS AND 9 HOURS OLD, AND THE TUBING WAS SUSPECTED TO BE THE SAME AGE, AS THE PWD STATED HE CHANGES TUBING WHEN CHANGING THE CASSETTE. GLUCOSE WAS 173 MG/DL AT THE TIME. PSS EXPLAINED THE IMPORTANCE OF CHANGING ALL SUPPLIES EVERY 2¿3 DAYS AND ADVISED FILLING THE CASSETTE WITH ONLY ENOUGH INSULIN FOR THREE DAYS PLUS EXTRA FOR TUBING FILL. SITE PLACEMENT WAS DISCUSSED; THE PWD REPORTED USING ONLY INNER THIGHS, WHICH PSS CLARIFIED IS OFF LABEL, RECOMMENDING OUTER THIGHS AND OTHER APPROVED SITES. PSS ADVISED CHANGING THE CASSETTE AND TUBING SINCE THEY WERE OVER 4 DAYS OLD. THE PWD AGREED, CHANGED BOTH, AND FILLED THE CASSETTE FOR THREE DAYS OF USE. GLUCOSE ROSE TO 232 MG/DL DURING THE CALL. THE PWD STATED HE KEPT THE OLD CANNULA IN PLACE IN CASE THE NEW ONE CAUSED ALARMS AND CONNECTED NEW TUBING TO THE OLD SITE, WHICH WAS OVER 4 DAYS OLD, THEN DELIVERED AN OVERRIDE CORRECTION BOLUS OF 4.5U SUCCESSFULLY WITHOUT RECURRENCE OF THE ALARM. PSS ADVISED REMOVING THE NEW CANNULA TO CHECK FOR BENDING; THE PWD NOTED A SLIGHT CURVE BUT WAS UNSURE IF REMOVAL CAUSED IT. PSS EMPHASIZED THAT THE OLD SITE, DESPITE ALLOWING INSULIN FLOW, NEEDED REPLACEMENT DUE TO AGE AND ENCOURAGED USING ON-LABEL SITES. THE PWD AGREED TO USE THE LOVE HANDLE AREA. HE WAS ADVISED TO MONITOR GLUCOSE CLOSELY DUE TO THE OVERRIDE BOLUS AND SITE CHANGE. GLUCOSE WAS 167 MG/DL BY THE END OF THE INTERACTION. THE PWD WILL RETURN THE CASSETTE AND INFUSION SET. THE PWD EXPRESSED WILLINGNESS TO FOLLOW PSS GUIDANCE TO CHANGE SUPPLIES EVERY 3 DAYS AND ROTATE SITES TO REDUCE LINE BLOCKED ALARMS. PSS FOLLOWED UP AFTER THE GLUCOSE SPIKE TO CONFIRM IMPROVEMENT. THE PWD REPORTED REMOVING THE OLD SITE AND PLACING A NEW CLEO 90 CANNULA IN A NEW LOCATION, WHICH RESOLVED THE ISSUE, AS GLUCOSE DROPPED TO 87 MG/DL AND WAS PREDICTED TO GO LOWER. PSS CONFIRMED THE PWD HAD RESCUE CARBS AND ADVISED CONTINUED MONITORING. ON (B)(6) 2025 (B)(4), A FOLLOW-UP CALL REVEALED THE PWD ATTEMPTED TO USE THE LOVE HANDLE SITE BUT EXPERIENCED SIGNIFICANT BLEEDING UPON INSERTION OF THE CLEO 90 INFUSION SET, REQUIRING REMOVAL AND REPEATED PRESSURE TO STOP BLEEDING. THE PWD THEN INSERTED A NEW SET INTO THE THIGH. ON (B)(6) 25 THE PWD CONTINUED TO EXPERIENCE CONTINUOUS/DAILY LINE BLOCKED ALARMS. THE MOST RECENT LINE BLOCKED ALARM EVENT OCCURRED. THE FIRST LINE BLOCKED ALARM EARLIER TODAY WAS ADDRESSED BY PWD THROUGH A FULL SUPPLY CHANGE, INCLUDING INFUSION SET AND CASSETTE (NOT AN ICU MED DEVICE). SINCE THEN, PWD RECEIVED TWO ADDITIONAL LINE BLOCKED ALARMS, WHICH WERE RESOLVED USING THE CURRENT CASSETTE. PSS ADVISED THAT IF ANOTHER LINE BLOCKED ALARM OCCURS, PWD SHOULD ATTEMPT TO CHANGE THEIR SITE INDEPENDENTLY OF THE CASSETTE, AND IF THE ISSUE PERSISTS, PERFORM A FULL SUPPLY CHANGE INCLUDING THE CASSETTE. PWD WAS PREVIOUSLY ADVISED TO USE THE ABDOMEN FOR SITE PLACEMENT BUT STATED IT WAS UNCOMFORTABLE; HOWEVER, THEY AGREED TO TRY USING THE ABDOMEN AGAIN. THE OPERATOR OF THE DEVICE WAS A LAY USER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565130 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. NI 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male