BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT

    MDR report key: 22676325 · Received July 31, 2025

    Report

    Report Number
    3012307300-2025-09103
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 31, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    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 CASSETTE WAS CONNECTED TO THE PUMP, AN OCCLUSION ALARM OCCURRED. POSSIBLE LOT NUMBERS- 3648345 AND 4213387. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213384 CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown