AMSCO C STERILIZER

Description of Event or Problem

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

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE UNIT AND FOUND THE VIEW PORT HAD BECOME DAMAGED ALLOWING WATER AND STEAM TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE VIEW PORT, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN COLLECTED WATER SAMPLES TO BE TESTED. THE RESULTS IDENTIFIED THAT ONE OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WAS ABOVE THE MAXIMUM REQUIREMENTS AND ONE WAS BELOW THE MINIMUM REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE AMSCO C STERILIZER OPERATOR MANUAL (TABLE 7-3. REQUIRED FEED WATER QUALITY FOR CARBON STEEL GENERATORS). THE USER FACILITY IS RESPONSIBLE FOR ENSURING THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE ELECTRIC STEAM GENERATOR'S OPERATING REQUIREMENTS. THE AMSCO C STERILIZER OPERATOR MANUAL STATES (3-1), "WATER QUALITY - SUPPLIED MUST BE WITHIN SPECIFICATIONS. IMPROPER WATER QUALITY ADVERSELY AFFECTS EQUIPMENT OPERATION." THE TECHNICIAN NOTIFIED THE CUSTOMER OF THE WATER QUALITY TEST RESULTS AND THAT THEIR WATER QUALITY IS NOT MEETING THE REQUIRED OPERATING CONDITIONS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.