AMSCO 400 STERILIZER

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER WAS LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THE UNIT HAD BEEN SHUT DOWN BY THE USER FACILITY. AFTER FURTHER INSPECTION, THE TECHNICIAN FOUND THAT AN INCOMING WATER LINE HAD BROKEN. THIS WATER LINE IS THE USER FACILITY'S WHICH IS CONNECTED TO THE AMSCO 400 STERILIZER. ADDITIONALLY, THE TECHNICIAN FOUND THAT ONE OF THE CHECK VALVES WAS NOT OPERATING PROPERLY. THE CHECK VALVE WAS RETURNED TO STERIS FOR EVALUATION. UPON INSPECTION, SEDIMENT WAS OBSERVED INSIDE THE CHECK VALVE. THE SEDIMENT IS INDICATIVE OF POOR WATER QUALITY AT THE USER FACILITY. WATER SAMPLES WERE TAKEN FROM THE USER FACILITY WHICH CONFIRMED THAT FOUR OF THE CRITICAL ATTRIBUTES OF WATER QUALITY WERE OUTSIDE THE REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE AMSCO 400 STERILIZER OPERATOR MANUAL (TABLE 5.1 REQUIRED FEED WATER QUALITY FOR CARBON STEEL STEAM GENERATORS). THE TECHNICIAN REPLACED THE CHECK VALVE, TESTED THE FUNCTION AND OPERATION OF THE STERILIZER, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.