BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24749046 · Received March 31, 2026

    Report

    Report Number
    3012307300-2026-03121
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 7, 2026
    Report Date
    March 31, 2026
    Manufacturer
    ICU MEDICAL, INC
    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 PERSON WITH DIABETES (PWD) EXPERIENCED MULTIPLE LINE BLOCKED ALARMS. PWD REPORTS HE RESOLVED WITH CURRENT CASSETTE, CHECKED TUBING FOR KINKS, CHANGED SITE AND CHANGED CASSETTE HOWEVER THE ISSUE PERSISTED. PWD THEN CHANGED SITE AND PLACED A FEW INCHES AWAY FROM ORIGINAL SITE. PWD REPORTS HE THEN RECEIVED ANOTHER LINE BLOCKED ALARM. PWD PERFORMED SAME TROUBLESHOOTING STEPS AND CHANGED THE SITE ANOTHER FEW INCHES AWAY FROM THE LAST SITE. PWD REPORTS HE THEN RECEIVED ANOTHER LINE BLOCKED ALARM, PROMPTING HIM TO REMOVE THE PUMP AND REVERT BACK TO BACKUP INSULIN THERAPY. WHEN REMOVING SITES, PWD REPORTS BOTH APPEAR TO BE SLIGHTLY BENT. PWD SUCCESSFULLY PLACED NEW SITE ON THIGH HOWEVER RECEIVED ANOTHER LINE BLOCKED ALARM WHILE ON THE CALL. PWD RESUMED WITH CURRENT CASSETTE AFTER ENSURING TUBING IS POSITIONED STRAIGHT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THE OPERATOR OF THE DEVICE WAS THE LAY USER OR PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809783 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC 4468682 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male