BEUDAMED
    FDA Adverse Event Summary report: N

    3017 ETO STERILIZER

    MDR report key: 6195965 · Received December 21, 2016

    Report

    Report Number
    3005899764-2016-00090
    Date Received
    December 21, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 21, 2016
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING STERIS' INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EO CARTRIDGE LEAK WAS CONTAINED WITHIN THE STERILIZER AND NO EO LEAKED OUTSIDE OF THE UNIT. THE STERILIZER OPERATED PROPERLY WHEN THE EO CARTRIDGE LEAK WAS DETECTED. AN EXHAUST AND AIR WASH SEQUENCE IN THE STERILIZER OCCURRED AND THE CHAMBER DOOR REMAINED LOCKED. WHEN THIS SEQUENCE OCCURS ONLY A QUALIFIED SERVICE TECHNICIAN CAN UNLOCK THE CHAMBER DOOR. THE STERIS TECHNICIAN TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING PROPERLY. THE UNIT WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. THE EO CARTRIDGE SUBJECT OF THE REPORTED EVENT WAS NOT RETURNED TO STERIS FOR EVALUATION. INVESTIGATION WITH THE EO CARTRIDGE SUPPLIER IDENTIFIED ACTIONS TO BETTER CONTROL VARIATION ENCOUNTERED PERIODICALLY DURING CARTRIDGE PRODUCTION. AFTER COMPLETION OF THESE ACTIONS, THERE HAVE BEEN NO FURTHER OCCURRENCES OF CARTRIDGE LEAKS.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED THEIR 3017 ETO STERILIZER WAS FAILING CYCLES DUE TO A "FAILURE TO HOLD VACUUM" ALARM. A STERIS SERVICE TECHNICIAN ARRIVED ON-SITE, OPENED THE STERILIZER DOOR TO INSPECT THE UNIT, AND IDENTIFIED THE EO CARTRIDGE WAS LEAKING ETHYLENE OXIDE. THIS LEAK WAS THE CAUSE OF THE "FAILURE TO HOLD VACUUM" ALARM. WHEN THE TECHNICIAN OPENED THE STERILIZER TO INSPECT THE CARTRIDGE, THE USER FACILITY'S EO MONITORING SYSTEM ALARMED DUE TO THE PRESENCE OF ETHYLENE OXIDE AND THE DEPARTMENT WAS EVACUATED. THE TECHNICIAN PLACED THE EO CARTRIDGE BACK INTO THE STERILIZER TO CONTAIN THE LEAK. IN ACCORDANCE WITH RECOMMENDED PRACTICES FROM STERIS SERVICE ENGINEERING SEVERAL CYCLES WERE RUN TO DISPOSE OF THE REMAINING ETHYLENE OXIDE. THERE WERE NO REPORTED INJURIES AS A RESULT OF THE ETHYLENE OXIDE LEAK. WHEN THE TECHNICIAN IDENTIFIED THE LEAK, HE RAN SEVERAL CYCLES TO EMPTY THE EO CARTRIDGE. THE TECHNICIAN REPLACED THE EO CARTRIDGE, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE EMPTY EO CARTRIDGE IS BEING RETURNED TO STERIS FOR EVALUATION. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR 3017 ETO STERILIZER WAS FAILING CYCLES. NO INJURY, PROCEDURE DELAY, OR CANCELLATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846878 3017 ETO STERILIZER STERILIZER FLF STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1