BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24638431 · Received March 19, 2026

    Report

    Report Number
    3012307300-2026-02679
    Event Type
    Malfunction
    Date Received
    March 19, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPA
    UDI-DI
    10610586028335
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D3 AND D4 - UPDATED. G1 - UPDATED. H6 ¿ UPDATED. NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. THE DEVICE HISTORY FILE WAS REVIEWED. THERE WERE NO NON-CONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: 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 PWD¿S CURRENT BLOOD GLUCOSE WAS 358 MG PER DL BY FINGERSTICK. THE PUMP (NOT AN ICU MEDICAL PRODUCT) AND INFUSION SITE WERE FUNCTIONING PROPERLY. THE PWD LATER CALLED TO REPORT ADHESIVE-RELATED ISSUES WITH FOUR CLEO 90 INFUSION SETS. OVER THE PAST 24 HOURS, THE PWD EXPERIENCED MULTIPLE PROBLEMS, INCLUDING THE INFUSION SITE NOT RELEASING FROM THE APPLICATOR, FAILURE OF THE SET TO ADHERE UPON INSERTION, LEAKAGE AT THE SITE, AND ANOTHER SITE BEING PULLED OUT DURING WEAR. AT THE TIME OF THE CALL, THE PWD¿S BLOOD GLUCOSE WAS 500 MG PER DL BY FINGERSTICK, WITH A CGM READING OF 401 MG PER DL. THE PWD DID NOT REQUIRE EMERGENCY MEDICAL SERVICES BUT REPORTED SHORTNESS OF BREATH AND TRACE KETONES. THE PWD¿S SON WAS AT HOME IN CASE OF AN EMERGENCY. THE PWD ADMINISTERED INSULIN VIA MDI AND WAS FOLLOWING THE STICKS METHOD. THE PSS SUGGESTED USING THE ROCKING METHOD FOR INSERTION. THE PWD EXPRESSED SIGNIFICANT FRUSTRATION, DESCRIBING THE CLEO 90 INFUSION SET AS ¿A PIECE OF JUNK,¿ AND VOICED CONCERNS THAT THE CANULA LENGTH WAS CONTRIBUTING TO INSULIN LEAKAGE. THE PSS ENCOURAGED THE PWD TO ATTEMPT ANOTHER SITE INSERTION. THE PWD SUCCESSFULLY PLACED A NEW INFUSION SET AND DELIVERED AN ADDITIONAL BOLUS. THE PWD INQUIRED ABOUT OTHER COMPATIBLE INFUSION SETS. THE PWD STATED UNCERTAINTY ABOUT CONTINUING WITH THE PRODUCT, NOTING THIS WAS ONLY THEIR SECOND DAY USING THE TWIIST PUMP (NOT AN ICU MEDICAL PRODUCT). THE PSS PLANNED TO FOLLOW UP WITH THE PWD IN ONE HOUR TO CONFIRM PUMP AND SITE FUNCTIONALITY. THERE WAS NO PATIENT INJURY. PATIENT DETAILS WERE PROVIDED: THE PATIENT IS A NON-HISPANIC/LATINO, WHITE 42-YEAR-OLD FEMALE, WEIGHING 220 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699940 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 4468682 10610586028335

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female