AMSCO

Additional Manufacturer Narrative

THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER TO ENSURE THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE UNIT'S OPERATING REQUIREMENTS. RESULTS FOR THE FACILITY'S COLLECTED WATER SAMPLES 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 TECHNICIAN NOTIFIED USER FACILITY PERSONNEL 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 UNIT AND FOUND THAT STEAM WAS LEAKING FROM THE VIEWPORT. THE TECHNICIAN REPLACED THE VIEWPORT, CONFIRMED THE UNIT BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER TO ENSURE THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE UNIT'S OPERATING REQUIREMENTS; RESULTS ARE PENDING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED A STEAM LEAK AND "LOUD NOISE" FROM THEIR AMSCO 400 STERILIZER. AS A RESULT, AN EMPLOYEE EXPERIENCED RINGING IN THEIR EARS. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.