BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT

    MDR report key: 23583700 · Received November 18, 2025

    Report

    Report Number
    3012307300-2025-12559
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    October 21, 2025
    Report Date
    January 2, 2026
    Manufacturer
    ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V
    Product Code
    LHI
    UDI-DI
    10610586044014
    PMA / PMN Number
    K162219
    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 INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    D3: MFG. ESTABLISHMENT NAME UPDATED. H3: THIRTY-THREE UNOPENED AND FIVE USED NRFIT CASSETTE RESERVOIRS (LOT 6101798) WERE RETURNED AND EVALUATED. VISUAL INSPECTION IDENTIFIED NO DAMAGE OR ANOMALIES AS RECEIVED. FUNCTIONAL LEAK TESTING OF ALL 38 UNITS CONFIRMED LEAKAGE AT THE TUBING-TO-FEMALE LUER BOND IN FOUR UNOPENED SAMPLES AND ALL FIVE USED SAMPLES. FURTHER INSPECTION OF THE LEAKING UNITS IDENTIFIED SPOTTY SOLVENT COVERAGE AND SOLVENT CHANNELING AT THE LUER-TO-TUBE BOND INTERFACE. DIMENSIONAL AND TENSILE TESTING OF AFFECTED COMPONENTS MET APPLICABLE MANUFACTURING SPECIFICATIONS. THE COMPLAINT OF LEAKAGE IS CONFIRMED. ROOT CAUSE ANALYSIS IS BEING ADDRESSED UNDER A FORMAL CAPA INVESTIGATION. NO ADDITIONAL COMPLAINT-LEVEL INVESTIGATION ACTIVITIES ARE PENDING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN INJECTING MEDICINE, THERE IS LEAKAGE BETWEEN THE CONNECTOR AT THE TIP AND THE TUBE. THE LEAKAGE OCCURS EVEN WHEN THE INJECTION IS DONE SLOWLY. THE EVENT OCCURRED BEFORE PATIENT USE/DURING PRIMING AT FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1864008 CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V 6101798 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown