ETHYLENE OXIDE STERILANT
Received Feb 15, 2017 · Event occurred Jan 19, 2017
Report 1937531-2017-00003 · MDR key 6332473
Device
Product problems
- Device Displays Incorrect Message
- Device Operates Differently Than Expected
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 SERVICEMAN 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.
Additional Manufacturer Narrative
THE FAILED TO HOLD VACUUM ALARM WAS ATTRIBUTED TO AN EO CARTRIDGE LEAK. 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 SERVICEMAN CAN UNLOCK THE CHAMBER DOOR. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER. DURING THE TECHNICIAN'S INSPECTION, HE CONFIRMED THE 3017 ETO STERILIZER HAD ALARMED DUE TO AN EO CARTRIDGE LEAK. THE TECHNICIAN TESTED THE STERILIZER AND FOUND IT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE STERILIZER AND THE UNIT WAS RETURNED TO SERVICE. THE OPERATOR MANUAL STATES (PP. 6-6), "THE CHAMBER DOOR(S) REMAINS LOCKED UNTIL COMPLETION OF THE PROGRAMMED EXHAUST OR AERATION PHASE OR DURING POWER FAILURE." THE OPERATOR MANUAL STATES (PP. 2-2), "THE DOOR LOCK REMAINS LOCKED THROUGHOUT THE ENTIRE CYCLE, EVEN IF POWER IS REMOVED, NO MATTER WHAT THE CHAMBER PRESSURE IS. THE CHAMBER DOOR CANNOT BE OPENED IF THE LOCK IS ENGAGED." THE OPERATOR MANUAL STATES (PP. 2-3), "THE CHAMBER TEMPERATURE AND VACUUM ARE CONTINUALLY MONITORED THROUGHOUT THE CYCLE, AND IN THE EVENT OF ANY ABNORMALITY, THE NORMAL EXHAUST AND AIR WASH SEQUENCE IS PERFORMED BEFORE THE DOOR IS UNLOCKED." THE 3017 STERILIZER REMAINS IN SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS TO DETERMINE THE CAUSE OF THE EO CARTRIDGE LEAK. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
THE USER FACILITY REPORTED THEIR 3017 ETO STERILIZER ALARMED DUE TO A FAILURE TO HOLD VACUUM. NO INJURY, PROCEDURE DELAYS OR CANCELLATIONS WERE REPORTED.