AMSCO EVOLUTION

Additional Manufacturer Narrative

DUE TO THE DAMAGE THAT THE STEAM GENERATOR SUSTAINED, THE STERIS SERVICE TECHNICIAN REPLACED THE STEAM GENERATOR, TESTED THE FUNCTION AND OPERATION OF THE DEVICE, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE EVOLUTION STERILIZER WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. A STERIS SERVICE TECHNICIAN COLLECTED WATER SAMPLES TO BE TESTED. THE RESULTS IDENTIFIED THAT THREE OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE MAXIMUM REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE MEDIUM EVOLUTION 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 MEDIUM EVOLUTION 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.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE INTERNAL STEAM GENERATOR HAD CRACKS ALONG THE WELDING. THE TECHNICIAN ALSO FOUND SCALE BUILD UP WITHIN THE STEAM GENERATOR DUE TO THE FACILITY WATER QUALITY. AS THE STEAM GENERATOR HAD CRACKS ALONG THE WELDING, THIS ALLOWED WATER TO LEAK FROM THE UNIT. THE UNIT HAS BEEN REMOVED FROM SERVICE AS IT IS PENDING REPAIRS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR EVOLUTION STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY. REPORT OF PROCEDURE DELAYS.

Additional Manufacturer Narrative

UDI RELATED DATA QUALITY UPDATES ONLY - ALIGNMENT WITH GUDID.