BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD EXTENSION SETS NRFIT

    MDR report key: 22676240 · Received July 31, 2025

    Report

    Report Number
    3012307300-2025-09102
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 31, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    LHI
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 WHEN THE EXTENSION SET WAS CONNECTED TO THE PUMP, AN OCCLUSION ALARM OCCURRED. POSSIBLE LOT NUMBERS- 4183712, 4170320, 4146561, 4120091 AND 4257052. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2417647 CADD EXTENSION SETS NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI ICU MEDICAL, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown