AMSCO

Additional Manufacturer Narrative

THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER, AND THE RESULTS IDENTIFIED THAT THREE 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 STERIS AREA SERVICE MANAGER NOTIFIED THE CUSTOMER OF THE WATER QUALITY TEST RESULTS AND THAT THEIR WATER QUALITY IS NOT MEETING THE REQUIRED OPERATING CONDITIONS. THE USER FACILITY HAS COMMITTED TO MAKING THE NECESSARY IMPROVEMENTS TO THE FACILITY'S INCOMING WATER QUALITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE AMSCO 400 STERILIZER AND FOUND THE VIEW PORT ON THE STERILIZER'S STEAM GENERATOR WAS DAMAGED. AS THE VIEW PORT WAS DAMAGED, THIS ALLOWED WATER AND STEAM TO LEAK OUT ONTO THE FLOOR. THE TECHNICIAN REPLACED THE VIEW PORT, TESTED THE FUNCTION AND OPERATION OF THE DEVICE AND CONFIRMED IT TO BE OPERATING TO SPECIFICATIONS. THE UNIT WAS RETURNED TO SERVICE, AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT STEAM AND WATER LEAKED FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.