BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2930005 · Received January 25, 2013

    Report

    Report Number
    3000251274-2013-00012
    Date Received
    January 25, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 25, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING INITIAL DISCUSSIONS WITH THE CUSTOMER, THE EMPLOYEES EXPRESSED AN INTEREST IN SCHEDULING AN IN-SERVICE ON USAGE OF PPE, PROPER DISPOSAL OF S40 STERILANT AND PROPER OPERATION OF THE SYSTEM 1E. ON (B)(4), 2013, THE STERIS ACCOUNT MANAGER CONFIRMED THAT THE CUSTOMER HAD CHANGED THEIR DECISION, AND DECLINED IN-SERVICE.THE CUSTOMER STATED "THIS WAS AN UNUSUAL CIRCUMSTANCE THAT HAS BEEN CORRECTED WITH A NEW POLICY AND PROCEDURE FOR DISPOSING OF UNUSED STERILANT."

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE EQUIPMENT AND FOUND THE UNIT HAD ABORTED THE PREVIOUS CYCLE DUE TO FILL TIME ERROR. THE TECHNICIAN INSPECTED THE UNIT, AND FOUND NO ISSUES WITH THE SYSTEM 1E. HOWEVER, THE TECHNICIAN MEASURED THE INCOMING WATER PRESSURE, AND FOUND IT TO BE 10 PSI DYNAMIC. THE TECHNICIAN ASSISTED THE FACILITY PLUMBER IN TROUBLESHOOTING THE ISSUE, AND DISCOVERED INCOMING WATER FLOW WAS REDUCED BY AN OBSTRUCTION IN THE PLUMBING LINE. THE FACILITY PLUMBER INSTALLED A NEW SHUT OFF VALVE. THE TECHNICIAN MEASURED THE INCOMING WATER PRESSURE, AND FOUND IT TO BE 50 PSI STATIC AND 40 PSI DYNAMIC (REQUIRED SPECIFICATION OF INCOMING WATER PRESSURE IS (B)(4)). THE TECHNICIAN RAN DIAGNOSTIC AND PROCESSING CYCLES AND FOUND THE UNIT OPERATIONAL. THE UNIT WAS RETURNED TO SERVICE. ALL INSTRUMENTS PRESENT IN THE UNIT DURING THE FAILED CYCLE WERE REPROCESSED PRIOR TO USE. THE OPERATOR MANUAL FOR SYSTEM 1E (PAGE 1-2) STATES "APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) IS REQUIRED WHEN HANDLING OR DISPOSING OF PARTIALLY FILLED, LEAKING, DAMAGED, OR EXPIRED CONTAINERS OF S40 STERILANT CONCENTRATE. MINIMALLY, PPE SHOULD CONSIST OF CHEMICAL-RESISTANT GLOVES, APRON, GOGGLES OR FACE SHIELD, AND ANY OTHER PROTECTION REQUIRED BY FACILITY PROCEDURES." THE CAUSE OF THE FAILED CYCLE WAS DUE TO AN OBSTRUCTION WITH THE FACILITY PLUMBING. THE CAUSE OF THE BURNING SENSATION WAS DUE TO IMPROPER PPE AND IMPROPER DISPOSAL OF A PARTIALLY FILLED S40 CONTAINER. THE USER SHOULD NOT HAVE REMOVED THE TRAY WITH THE CUP STILL LOADED INTO THE WELL. THE OPERATOR MANUAL FOR SYSTEM 1E (PAGES 7-15 AND 7-16) STATES THAT UPON CANCELLATION OF A CYCLE, THE LID SEAL DEFLATES AND THE UNIT PROMPTS THE OPERATOR TO DISPOSE OF STERILANT. STERIS HAS OFFERED THE CUSTOMER AN IN-SERVICE ON USAGE OF PPE, PROPER DISPOSAL OF S40 STERILANT, AND PROPER OPERATION OF THE SYSTEM 1E. THE CUSTOMER HAS ACCEPTED, AND IS WORKING WITH THE STERIS ACCOUNT MANAGER TO SCHEDULE THE IN-SERVICE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A FACILITY EMPLOYEE RECEIVED A CHEMICAL BURN AFTER REMOVING A SYSTEM 1E TRAY FROM THE 1E PROCESSOR. A PROCESSING CYCLE ABORTED DUE TO LOW FILL TIME. THE EMPLOYEE OPERATING THE UNIT REMOVED THE TRAY WITH THE S40 CUP IN IT, AND ATTEMPTED TO MOVE THE TRAY AND CUP INTO ANOTHER ADJACENT UNIT. THE INSIDE OF THE EMPLOYEE'S BARE RIGHT FOREARM CONTACTED THE TRAY. THE EMPLOYEE FELT A BURNING SENSATION. THE AFFECTED AREA OF SKIN (APPROXIMATELY 1" X 1/8" IN SIZE) WAS RINSED WITH WATER. NO BLISTERING WAS REPORTED. THE ASSOCIATE WENT TO THE ER, AND THE ER STAFF INSTRUCTED HER TO RINSE WITH MORE WATER. THE EMPLOYEE DID NOT MISS ANY TIME FROM WORK. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35224 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other