BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24626934 · Received March 18, 2026

    Report

    Report Number
    3012307300-2026-02632
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 18, 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

    H3/H6: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILLED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED CHANGING THE CASSETTE (NOT AN ICU MEDICAL PRODUCT) AND THE CLEO 90 INFUSION SET EARLIER TO CLEAR A LINE-BLOCKED ALARM, HOWEVER, PWD LATER RECEIVED A CASSETTE-EMPTY ALARM DESPITE 250 UNITS REMAINING. CPS ASSISTED PWD IN RESOLVING THE CASSETTE-EMPTY ALARM, AND AFTER PRIMING THE TUBING, THE PWD CONFIRMED NO BUBBLES WERE PRESENT AND OBSERVED INSULIN DROPS AT THE END OF THE TUBING, ALLOWING PWD TO RESUME DELIVERY SUCCESSFULLY. PWD ALSO REPORTED RECEIVING THE LINE-BLOCKED ALARM TWICE AND CONFIRMED THERE WERE NO KINKS IN THE TUBING. PSS ADVISED THAT PWD HAD PERFORMED THE CORRECT TROUBLESHOOTING STEPS AND RECOMMENDED CHANGING THE CASSETTE, AND THE PWD STATED THEY WOULD ALSO CHANGE THE CLEO 90 INFUSION SET. PSS INFORMED PWD THAT BOTH THE CASSETTE AND INFUSION SET COULD BE REPLACED. THE ALERT RECEIVED WAS ¿LINE BLOCKED,¿ AND ATTEMPTS TO RESOLVE IT WITH THE CURRENT CASSETTE WERE UNSUCCESSFUL, SO THEY PROCEEDED WITH CHANGING BOTH COMPONENTS. THERE WAS PATIENT INVOLVEMENT/NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686513 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female