AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE VIEWPORT WAS DAMAGED ALLOWING WATER AND STEAM TO LEAK FROM THE UNIT. THE TECHNICIAN REPLACED THE VIEWPORT, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED THE STERILIZER TO SERVICE. WHILE ONSITE, THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER. A FOLLOW-UP MDR WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER EMITTED A "LOUD BANG" NOISE FOLLOWING A WATER AND STEAM LEAK. DUE TO THE LOUD NOISE, THE USER FACILITY SENT THE EMPLOYEE IN THE ROOM AT THE TIME OF THE REPORTED EVENT TO A HEARING CONSULTATION. THE USER FACILITY DID NOT DISCLOSE ANY ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

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 AND ONE OF THE CRITICAL ATTRIBUTES WAS BELOW THE REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE AMSCO 400 STERILIZER OPERATOR MANUAL (TABLE 5-1. 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 400 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.