AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND DID NOT OBSERVE ANY LEAKS FROM THE UNIT. THE TECHNICIAN LEARNED FROM USER FACILITY PERSONNEL THAT THEY HAD ALREADY MADE REPAIRS TO THE UNIT BY REPLACING THE WATER FEED LINE. DURING THE INSPECTION, THE TECHNICIAN FOUND THAT THE CHECK VALVES WERE NOT OPERATING PROPERLY AND REQUIRED REPLACEMENT. THE ISSUE WITH THE CHECK VALVES ALLOWED WATER TO MOVE BACKWARDS TO THE WATER FEED LINE RESULTING IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE CHECK VALVES, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. A 3-YEAR COMPLAINT REVIEW CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR WATER FEED LINE TO THE AMSCO C STERILIZER STEAM GENERATOR DETACHED CAUSING A WATER LEAK. NO REPORT OF INJURY.