BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24144785 · Received January 22, 2026

    Report

    Report Number
    3012307300-2026-00470
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 28, 2025
    Report Date
    April 1, 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: NO PRODUCT RETURNED FOR DEVICE ANALYSIS; A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE. NO PRODUCT WAS RETURNED; THEREFORE, NO VISUAL AND FUNCTIONAL TESTS WERE PERFORMED, THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PWD CALLED TO REPORT A ¿LINE BLOCKED¿ ALARM THAT OCCURRED ON SUNDAY, ON (B)(6) 2025. THE PWD STATED THAT AFTER RECEIVING THE ALARM, THE INFUSION SET SITE WAS CHANGED. UPON REMOVING THE SITE, THE AREA BEGAN TO BLEED. THE PWD BELIEVES A VEIN MAY HAVE BEEN HIT, AS THE SITE WAS WORN ON THE LEG. WHILE ATTEMPTING TO REPLACE THE SITE, THE CLEO 90 INFUSION SET DID NOT ADHERE UPON INSERTION, AND THE SITE REMAINED ATTACHED TO THE APPLICATOR. THE PWD REPORTED FOLLOWING THE STICKS METHOD. THE PSS PROVIDED EDUCATION ON USING THE TAP METHOD AND THE JOYSTICK METHOD FOR APPLICATOR REMOVAL, WHICH THE PWD UNDERSTOOD AND ACKNOWLEDGED. THE PWD STATED THAT THE NEEDLE STILL APPEARED STRAIGHT AND ATTEMPTED TO REINSERT THE SAME SITE. THE SITE INSERTED AND ADHERED SUCCESSFULLY, BUT SHORTLY AFTERWARD, THE PWD RECEIVED ANOTHER ¿LINE BLOCKED¿ ALARM. THE PWD THEN CHOSE TO COMPLETE A FULL SUPPLY CHANGE, INCLUDING CASSETTE, TUBING, AND INFUSION SET. THE PWD SUCCESSFULLY COMPLETED THE SUPPLY CHANGE AND RESUMED INSULIN DELIVERY. THE PWD DOES NOT HAVE IMPACTED SUPPLIES AVAILABLE FOR RETURN. 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
    207320 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7220 4461418 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male