BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEGACY CADD DUODOPA

    MDR report key: 24418714 · Received February 23, 2026

    Report

    Report Number
    3012307300-2026-01584
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 27, 2026
    Report Date
    March 17, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    H6 CODES: UPDATED. THE REPORTED DEVICE (CADD-LEGACY DUODOPA INFUSION PUMP) IS DISTRIBUTED AND MARKETED BY ABBVIE, LTD. AS THE SOLE COMBINATION PRODUCT APPLICANT AS DEFINED UNDER 21 CFR 4, SUBPART B. ABBVIE, LTD. HAS THE FDA REPORTING RESPONSIBILITY FOR THIS PRODUCT. ICU MEDICAL IS NOT REQUIRED TO PROVIDE REGULATORY REPORTS TO FDA FOR THIS PRODUCT.

    Description of Event or Problem · 0

    IT WAS STATED THAT THE ALARM KEEPS RINGING AND WON'T STOP. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT PATIENT'S HOME. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480199 LEGACY CADD DUODOPA AMBULATORY PUMPS FRN ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown