AMSCO

Additional Manufacturer Narrative

OUR INVESTIGATION INTO THE REPORTED EVENT IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED A STEAM LEAK FROM THEIR AMSCO 400 STEAM STERILIZER. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE VIEW PORT WAS DAMAGED ALLOWING WATER AND STEAM TO LEAK FROM THE STERILIZER. FURTHER INSPECTION REVEALED THAT THE WATER INLET CHECK VALVES TO THE STEAM GENERATOR ALSO REQUIRED REPLACEMENT. THE TECHNICIAN REPLACED THE VIEW PORT AND CHECK VALVES, TESTED THE STERILIZER, CONFIRMED THE UNIT TO BE OPERATING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER. TEST RESULTS IDENTIFIED THAT FOUR OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE MAXIMUM REQUIREMENTS FOR THE CARBON-STEEL STEAM GENERATOR AS STATED IN THE AMSCO 400 STERILIZER OPERATOR MANUAL (TABLE 5-1. REQUIRED FEED WATER QUALITY FOR CARBON-STEEL STEAM GENERATORS). THE USER FACILITY IS RESPONSIBLE FOR ENSURING THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE CARBON-STEEL STEAM GENERATOR'S OPERATING REQUIREMENTS. THE AMSCO 400 OPERATOR MANUAL STATES (3-1), "WATER QUALITY - SUPPLIED MUST BE WITHIN SPECIFICATIONS. IMPROPER WATER QUALITY ADVERSELY AFFECTS EQUIPMENT OPERATION." THE TECHNICIAN NOTIFIED USER FACILITY PERSONNEL OF THE WATER QUALITY TEST RESULTS AND THAT THEIR INCOMING WATER QUALITY IS NOT MEETING THE REQUIRED OPERATING CONDITIONS. THE USER FACILITY HAS COMMITTED TO MAKING THE NECESSARY IMPROVEMENTS TO THEIR WATER QUALITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.