BEUDAMED
    FDA Adverse Event Summary report: N

    S40 STERILANT CONCENTRATE

    MDR report key: 3202858 · Received July 2, 2013

    Report

    Report Number
    3000251274-2013-00058
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DID NOT REPORT ANY FAILED PROCESSOR CYCLES. IT WAS CONFIRMED THAT ALL CYCLES PASSED SUCCESSFULLY AND THE SYSTEM 1 EXPRESS AND SYSTEM 1 PLUS PROCESSORS ARE OPERATING PROPERLY. STERIS COLLECTED SAMPLES OF THE REPORTED RESIDUE AND FACILITY WATER FOR ANALYSIS. RESULTS OF THE ANALYSIS ATTRIBUTED THE STAINING TO AN INERT S40 INGREDIENT AND OTHER COMPOUNDS INTRODUCED BY THE FACILITY'S WATER. IT WAS DETERMINED THAT IMPROPER TRAY CLEANING PRACTICES CONTRIBUTED TO THE STAINING CONDITION. THE SYSTEM 1 EXPRESS AND SYSTEM 1 PLUS OPERATOR MANUALS INSTRUCT THE FOLLOWING REGARDING DAILY TRAY CLEANING PRACTICES: "WIPE THE INNER SURFACE AND SEAL, PROCESSING TRAY/CONTAINER, AND ACCESSORY RACK WITH A SOFT CLOTH DAMPENED WITH 70% ISOPROPYL ALCOHOL."A LETTER WAS SENT TO THE USER FACILITY ON 6/13/2013 EXPLAINING THE NEED TO CLEAN THE PROCESSING TRAY WITH 70% ISOPROPYL ALCOHOL DAILY AS DESCRIBED ABOVE AND INFORMING THAT CYTOTOXICITY TESTING PERFORMED DEMONSTRATED THE STAINING "IS NOT INDICATIVE OF A CONDITION THAT POSES RISK TO PATIENTS."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED RESIDUE AND YELLOW STAINING ON SYSTEM 1 EXPRESS AND SYSTEM 1 PLUS PROCESSOR TRAYS. THE FACILITY CANCELLED PATIENT PROCEDURES AS A RESULT OF THE REPORTED STAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302583 S40 STERILANT CONCENTRATE STERILANT MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other