BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD CLEO INFUSION SET

    MDR report key: 24771118 · Received April 2, 2026

    Report

    Report Number
    3012307300-2026-03248
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    March 10, 2026
    Report Date
    April 2, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    FPA
    PMA / PMN Number
    K042172
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 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 REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2026, CPS CONTACTED (B)(6), CDS, AND RELAYED THE HCP/PWD PLAN FOR THE PWD TO RESUME THERAPY AFTER MEETING WITH CDS. CPS ALSO CONTACTED THE PWD, WHO REPORTED BELIEVING THEY HAD CHANGED THE INFUSION SET AND CASSETTE AT HOME BEFORE GOING TO THE ER. THE PWD RECALLED THAT WHILE HER BG WAS HIGH AT HOME, SHE ATTEMPTED CORRECTION BOLUSES, BUT THE SYSTEM DID NOT RECOMMEND ADDITIONAL BOLUS DUE TO ACTIVE INSULIN. THE PWD WAS UNABLE TO REMEMBER EVENTS FROM (B)(6). UPON ER PRESENTATION, THE PWD WAS DESCRIBED AS INCOHERENT AND WAS TREATED WITH IV INSULIN AND FLUIDS, AND HER KIDNEYS WERE SCANNED FOR FUNCTION. HOSPITAL STAFF REPORTEDLY INFORMED HER THAT THE PWD ¿STUNK LIKE INSULIN,¿ ALTHOUGH WHEN THE PWD REMOVED THE INFUSION SET IN THE HOSPITAL, THEY DID NOT NOTE A BENT CANNULA AND THE ADHESIVE WAS SECURE. A HOSPITAL PHYSICIAN ATTEMPTED TO RESTART HER ON THE PUMP WITH A NEW CASSETTE AND INFUSION SET, BUT BG LEVELS DID NOT COME UNDER CONTROL, AND THE PUMP WAS REMOVED AGAIN. THE PHYSICIAN REPORTEDLY MADE SEVERAL PUMP-SETTING ADJUSTMENTS. THE PWD DID NOT RETAIN THE USED CASSETTES OR INFUSION SETS. THE PWD WAS DISCHARGED ON (B)(6) ON MDI AND PLANNED TO REMAIN ON MDI UNTIL AN IN-PERSON SESSION WITH CDS FOR PUMP RESTART AND ADDITIONAL EDUCATION. THE PWD REPORTED MEETING WITH THEIR HCP ON THE DAY OF THE CALL, RECEIVING A PRESCRIPTION FOR KETONE STRIPS, AND RECEIVING INSTRUCTIONS ON WHEN TO SEEK MEDICAL CARE. CPS RELAYED T2 FINDINGS THAT THE PUMP WAS FUNCTIONING AS INTENDED, AND A REPLACEMENT WAS PROCESSED. ON (B)(6) 2026, CDS (B)(6) PARTLOW REPORTED THAT THE PWD HAD BEEN HOSPITALIZED FOR DIABETIC KETOACIDOSIS (DKA), WITH HIGH BG BEGINNING (B)(6) AND PERSISTING UNTIL (B)(6), WHEN SHE WAS TAKEN TO THE ER. TIDEPOOL SHOWED BG >400 MG/DL WITHOUT ALARMS THAT MAY HAVE CONTRIBUTED. THE PWD WAS UNABLE TO RECALL WHETHER THEY ATTEMPTED AN INFUSION SET/CASSETTE CHANGE BEFORE HOSPITALIZATION AND REPORTED THAT ATTEMPTED BOLUSES WERE NOT RECOMMENDED BY THE APP. HOSPITAL STAFF SUSPECTED AN INFUSION-SITE LEAK BASED ON INSULIN ODOR ON CLOTHING. THE PWD WAS ADMITTED (B)(6) AND DISCHARGED (B)(6) ON MDI, WITH PLANS TO MEET HCP TO DISCUSS RESUMING PUMP THERAPY. THE OPERATOR OF THE DEVICE WAS LAY USER/PATIENT. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT. THERE WAS NO PATIENT INJURY. THE ISSUE WAS RESOLVED. PATIENT DETAILS WERE PROVIDED: THE PATIENT IS A 64 YR-OLD NON-HISPANIC/LATINO WHITE FEMALE WEIGHING 180 LBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825077 CADD CLEO INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization