BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SET

    MDR report key: 23066729 · Received September 16, 2025

    Report

    Report Number
    3012307300-2025-10717
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 24, 2025
    Report Date
    September 16, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED. THE REPORTED ISSUE CANNOT BE CONFIRMED AS NO PRODUCT WAS RETURNED FOR INVESTIGATION. IF THE PRODUCT IS RETURNED, THIS COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED WHICH INDICATED ALL INSPECTIONS WERE COMPLETED AND NO ISSUES WERE NOTED DURING MANUFACTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING EXHIBITED A NO DISPOSABLE ALARM. POSSIBLE LOTS 6093163, 6054041 AND 6076060. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659613 CADD EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown