BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNITY TOTAL PLUS COMBINED PROCEDURE PACK

    MDR report key: 24411525 · Received February 23, 2026

    Report

    Report Number
    1644019-2026-01047
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    January 23, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ALCON RESEARCH, LLC - HOUSTON
    Product Code
    LRO
    UDI-DI
    00380650003829
    PMA / PMN Number
    K880961
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6. AND H.11 ONLY THE INFUSION MANIFOLD CONNECTING TO THE YELLOW STOPCOCK AND THE 27GA INFUSION CANNULA LINE WAS RETURNED AND VISUALLY INSPECTED. FLUID WAS OBSERVED IN THE AIR LINE. THE INFUSION MANIFOLD WAS TESTED WITH THE LAB STOCK COMBINED FLUIDICS MANAGEMENT SYSTEM (FMS) AND OTHER COMPONENTS USING THE SYSTEM CONSOLE WITH THE CALIBRATED CONSOLE. THE PRODUCT PRIMED AND TUNED SUCCESSFULLY WITHOUT ANY SYSTEM MESSAGE CODE. HOWEVER, DURING FLUID AIR EXCHANGE (F/AX) FUNCTIONAL TEST, THE WET AUTO STOPCOCK FILTER RESTRICTED AIR TO TRAVEL TO THE INFUSION CANNULA TIP. THE INVESTIGATION CONDUCTED A NON-CONFORMANCE REVIEW OF THE REPORTED LOT NUMBER. NO RELEVANT DEVIATIONS WERE IDENTIFIED, ALL CORRESPONDING PRODUCTION RELEASE SPECIFICATIONS DEFINED IN THE DEVICE MASTER RECORD WERE MET. THE ROOT CAUSE OF THE CUSTOMER'S COMPLAINT WAS FOUND TO BE A LEAKY AUTO-INFUSION FILTER ALLOWING FLUID TO INGRESS INTO THE AIR INFUSION LINE, THIS IS KNOWN TO RESULT IN THE CUSTOMER'S EXPERIENCE. THIS DEFECT TYPE IS LIKELY RELATED TO AN ASSEMBLY ERROR OF THE AUTO STOPCOCK FILTER HOUSING DURING THE MANUFACTURING PROCESS. ACTION WILL NOT BE TAKEN BASED ON THIS OCCURRENCE. THE SUPPLIER HAS BEEN MADE AWARE OF THE ISSUE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR AND WILL TAKE ACTION FOR FUTURE OCCURRENCES AS DEEMED NECESSARY. COMPLAINT DATA FOR ALL PRODUCTS IS REVIEWED MONTHLY TO MONITOR FOR ADVERSE TRENDS. DURING THE LAST REVIEW, NO ADVERSE TRENDS WERE OBSERVED FOR THE REPORTED PRODUCT AND EVENT COMBINATION. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. NO FURTHER ACTION WARRANTED AT THIS TIME. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT AIR REPLACEMENT WAS NOT POSSIBLE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392471 UNITY TOTAL PLUS COMBINED PROCEDURE PACK GENERAL SURGERY TRAY (KIT) LRO ALCON RESEARCH, LLC - HOUSTON NA 17DPNK 00380650003829

    Patients

    Seq Age Sex Outcome Treatment
    1