BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24792641 · Received April 6, 2026

    Report

    Report Number
    3012307300-2026-03344
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 6, 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 THE PWD¿S FATHER CALLED IN TO REPORT PWD INFUSION SET FELL OUT LAST NIGHT WHILE SLEEPING. PWD FATHER REPORTS PWD NOTICED INFUSION SET WAS NOT ATTACHED THIS MORNING UPON WAKING. PWD FATHER DENIES ANY ALARMS, RISE IN BLOOD GLUCOSE, DAMAGE TO INFUSION SET OR ISSUES AT THE INFUSION SITE. PWD FATHER REPORTS THEY USE SKIN TAC TO PREP THE SKIN. PWD FATHER ALSO REPORTS PWD IS AWAITING A PUMP CLIP. PWD HAS BEEN PLACING PUMP NEXT TO HIM WHILE SLEEPING RATHER THAN CLIPPED ONTO PANTS. DISCUSSED POTENTIAL OF SLEEPING POSITION TO HAVE PULLED OUT TUBING. PWD FATHER RETAINED THE INFUSION SET FOR RETURN. THE INFUSION SET WAS LEAKING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850415 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 7220 UNKNOWN 30610586028339

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male