BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24872314 · Received April 14, 2026

    Report

    Report Number
    3012307300-2026-03684
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    March 19, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30610586028339
    PMA / PMN Number
    K042172
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERSON WITH DIABETES (PWD) REPORTED THEY EXPERIENCED CONTINUOUS GLUCOSE MONITOR (CGM) READING INTO THE 300'S. THE PWD CHECKED WITH A FINGER STICK (FS) WHICH ALIGNED WITH THE 300 MG PER DL. THE PWD THEN ADMINISTERED 3U HUMALOG VIA INJECTION AND CHANGED OUT THE SITE AS WELL. THERE WERE NO REPORTED ISSUES WITH OLD SITE, TUBING OR LEAKAGE, HOWEVER, NOTED A SMALL AMOUNT OF BLOOD IN THE OLD CANNULA. THE PWD REPORTED THEIR CGM READINGS WERE 120 MG PER DL. THE PWD DISCONNECTED THE TUBING FROM THE SITE AND PERFORMED FILL CANNULA WHICH GENERATED DROPLETS AT THE END OF THE TUBING. THE PWD STATED THAT THE SITE CHANGE RESOLVED THE ISSUE. NO PATIENT HARM OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933032 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. 4461418 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female