BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT

    MDR report key: 22680028 · Received July 31, 2025

    Report

    Report Number
    3012307300-2025-09136
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    January 1, 2025
    Report Date
    July 31, 2025
    Manufacturer
    SMITHS 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

    B3: UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. THIS FILE WAS ORIGINALLY INCORRECTLY FILED UNDER REGISTRATION NUMBER MRN 9617604-2025-00229. THE DATE OF THAT SUBMISSION WAS 13-JUNE-2025. ONE (1) USED DEVICE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED, AND THE REPORTED ISSUE COULD BE DUPLICATED. NO DAMAGE OR ANOMALIES WERE OBSERVED DURING THE INITIAL ASSESSMENT. IN ATTEMPTS TO REPLICATE CLINICAL USE THE CASSETTE WAS FILLED WITH 250ML OF WATER USING AN ICU MEDICAL PROVIDED SYRINGE. A LEAK WAS OBSERVED BETWEEN THE TUBING AND FEMALE LUER. FURTHER INSPECTION OF THE BOND SHOWED SPOTTY SOLVENT COVERAGE. THE LUER TUBE BOND WAS SEPARATED AND THE TUBE AND BOND POCKET WERE OBSERVED. SPOTTY SOLVENT COVERAGE WAS OBSERVED. THE PROBABLE CAUSE IS DUE TO INSUFFICIENT SOLVENT COVERAGE. 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

    AN EMAIL WAS RECEIVED REGARDING A MEDICATION CASSETTE WITH ITEM NUMBER 21-7609-24 AND LOT NUMBER 6012373. IT WAS STATED LIQUID LEAKAGE FROM THE CONNECTOR PART. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2239121 CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT SET, ADMINISTRATION, INTRAVASCULAR LHI SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 6012373 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown