BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA CLEAN SYSTEM

    MDR report key: 10940093 · Received December 2, 2020

    Report

    Report Number
    MW5098180
    Event Type
    Injury
    Date Received
    December 2, 2020
    Date of Event
    November 5, 2020
    Report Date
    December 1, 2020
    Manufacturer
    ULTRA CLEAN SYSTEM INC
    Product Code
    FLG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ULTRA CLEAN TRITON 72 DOES NOT PASS EFFICACY TESTS WHEN SANIZYME ENZYMATIC DETERGENT IS USED AND DOSED AT 1 OUNCE PER GALLON. EFFICACY TEST AND ACTIVE ENZYME TEST NOT PASSING WITH STERIS PROLYSTICA HP ENZYMATIC DETERGENT AND CHECK VALVE ON DETERGENT LINES WERE PLUGGED WITH DEBRIS. ONCE CHECK VALVES WERE REPLACED, EFFICACY TESTS WERE STILL NOT PASSING IN ALL LEVELS, HOWEVER ACTIVE ENZYME TEST STRIP PASSED. SONOCHECKS DO NOT PASS IN ALL LEVELS CONSISTENTLY. BASED ON THE EFFICACY TESTS AND SONOCHECK DEVICE, THIS SONIC MACHINES DESIGN DOESN'T HAVE ENOUGH SONICATION POWER TO REACH EVERY LEVEL WHEN ALL LUMEN BASKETS ARE TESTED TOGETHER. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402341 ULTRA CLEAN SYSTEM CLEANER, ULTRASONIC, MEDICAL INSTRUMENT FLG ULTRA CLEAN SYSTEM INC TRITON 72

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Other| R