3017 ETO STERILIZER
Received Dec 21, 2016 · Event occurred Dec 8, 2016
Report 3005899764-2016-00090 · MDR key 6195965
Device
Generic name
Sterilizer
Manufacturer
Steris Mexico, S. De R.l. De C.v.Product problems
- Failure to Cycle
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
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
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
THE USER FACILITY REPORTED THEIR 3017 ETO STERILIZER WAS FAILING CYCLES. NO INJURY, PROCEDURE DELAY, OR CANCELLATION WAS REPORTED.