inforMED

3017 EO GAS STERILIZER

Received Jun 12, 2014 · Event occurred May 22, 2014

Report 3005899764-2014-00039 · MDR key 3869715

Device

Generic name

Sterilizer

Product problems

  • Device Displays Incorrect Message

Patient

Not reported

  • No Known Impact Or Consequence To Patient

Narrative

Additional Manufacturer Narrative

THE FACILITY STATED THE LEAK WAS COMING FROM ONE OR SEVERAL ETO CANISTERS LOCATED IN THE STERILE PROCESSING ROOM WHICH HAD BEEN DAMAGED DURING TRANSPORT FROM THE FACILITY'S RECEIVING DEPARTMENT. THE FACILITY INFORMED THE STERIS TECHNICIAN THAT UPON RECEIPT OF THE ETO CANISTERS, THE FACILITY'S RECEIVING DEPARTMENT TOSSES THE CANISTERS INTO A PLASTIC BIN TO BE TRANSPORTED TO A FIRE PROOF CONTAINMENT BOX IN THE FACILITY'S SPD DEPARTMENT. THE FIRE DEPARTMENT AND HAZMAT TEAM ARRIVED AT THE FACILITY AND MOVED ALL OF THE ETO CANISTERS FROM THE FACILITY'S STORAGE CABINET INTO AN EMPTY 3017 EO GAS STERILIZER AND LOCKED THE STERILIZER DOOR. A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND PLACED THE STERILIZER INTO SERVICE MODE TO ALLOW ANY LEAKING CANISTER TO SLOWLY AERATE OVER A PERIOD OF SEVERAL DAYS. USING APPROPRIATE PPE, THE STERIS TECHNICIAN THEN RETURNED TO THE FACILITY, REMOVED THE CANISTERS FROM THE STERILIZER AND IDENTIFIED A SINGLE CANISTER WITH A VERY SMALL DENT IN ITS CAP. THE TECHNICIAN USED AN EO MONITOR AND CONFIRMED THE CANISTER WAS LEAKING EO GAS. ALL OTHER CANISTERS WERE INSPECTED AND NO SIGNS OF DAMAGE OR LEAKS WERE IDENTIFIED. THE TECHNICIAN PLACED THE DAMAGED CANISTER INTO THE EO STERILIZER, RAN A NORMAL CYCLE AND ENSURED THE CANISTER WAS EMPTIED OF ALL ETO AND PROPERLY AERATED. THE STERIS TECHNICIAN CONFIRMED THAT FOLLOWING THE EVENT, THE FACILITY HAS MODIFIED THE WAY THE CANISTERS ARE HANDLED ONCE RECEIVED IN HOUSE TO PREVENT ANY FURTHER ETO CANISTER LEAKS. NO FURTHER ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THEIR EO MONITOR SYSTEM ACTIVATED, ALERTING THE STERILE PROCESSING DEPARTMENT OF A POTENTIAL EO GAS LEAK. THE FIRE DEPARTMENT AND HAZMAT TEAM WERE DISPATCHED TO THE FACILITY IN RESPONSE TO THE ALARM. THE FACILITY'S DEPARTMENT WAS EVACUATED FOR OVER AN HOUR DUE TO THE ALARM AND POTENTIAL LEAK. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.