AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE AMSCO C SERIES STERILIZER AND FOUND THAT THE VIEWPORT WAS DAMAGED ALLOWING WATER TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE STERILIZER, CONFIRMED THE UNIT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. A FOLLOW-UP MDR WILL BE SUBMITTED PENDING THE RESULTS OF THE FACILITY'S COLLECTED WATER SAMPLES

Description of Event or Problem

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

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 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 USER FACILITY PERSONNEL OF THE WATER QUALITY TEST RESULTS AND THAT THEIR WATER QUALITY IS NOT MEETING THE REQUIRED OPERATING CONDITIONS. THE FACILITY HAS COMMITTED TO MAKING THE NECESSARY IMPROVEMENTS TO THEIR WATER QUALITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.