BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24618226 · Received March 17, 2026

    Report

    Report Number
    3012307300-2026-02538
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ICU MEDICAL 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

    D9: DATE RETURNED TO MFR: 3/18/2026. DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING DEVICE ANALYSIS. THE CUSTOMER REPORTED COMPLAINT OF BENT CANNULA WAS CONFIRMED BUT THE INFUSION SET CAUSING PUMP TO ALARM COULD NOT BE CONFIRMED. IT WAS FOUND THAT THE CANNULA WAS BENT, THE PROBABLE CAUSE IS UNKNOWN.

    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 PWD CALLED TO REPORT AN ACTIVE LINE BLOCKED ALARM ON A MILLYARD PRODUCT AND SUSPECTED THE ISSUE WAS RELATED TO THEIR INFUSION SITE, STATING THEY INTENDED TO REMOVE THE CANNULA. THE CANNULA TIP WAS DESCRIBED AS BENT, AND THE SITE HAD BEEN IN USE FOR TWO DAYS. THE CLEO 90 INFUSION SET REPORTEDLY CAUSED IRRITATION AND SWELLING FOR SEVERAL DAYS AFTER REMOVAL, OFTEN LEADING TO EARLY SITE CHANGES. THE PWD WAS PROVIDED WITH IRRITATION-MANAGEMENT TIPS FROM THE PANTHER DIABETES WEBSITE. NO DATES OR APPROXIMATE NUMBER OF PRIOR IRRITATION INCIDENTS WERE GIVEN. THE PWD WAS ADVISED TO KEEP THE BENT CANNULA FOR RETURN. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414788 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL S.A. DE C.V. 4461418 10610586028335

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female