BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24702512 · Received March 26, 2026

    Report

    Report Number
    3012307300-2026-02963
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 26, 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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEY COMPLETED A SET CHANGE YESTERDAY AND AFTER THEIR SGS STARTED GOING UP. PWD STATES THAT WHEN THEY REMOVED THE CANNULA, IT WAS BENT. STATES THAT AFTER SET CHANGE, THEIR SG STARTED TO GO DOWN. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766250 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7220 4461416 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male