CENTURY STERILIZER

Additional Manufacturer Narrative

THE USER FACILITY ELECTED TO HAVE THEIR BIOMED REPAIR THE UNIT. THE BIOMED REPLACED THE VIEWPORT, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS, AND RETURNED IT TO SERVICE. THE TECHNICIAN COLLECTED WATER SAMPLES TO TEST THE FACILITY'S INCOMING WATER AND THE RESULTS IDENTIFIED THAT TWO OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE MAXIMUM REQUIREMENTS FOR THE CARBON-STEEL STEAM GENERATOR AS STATED IN THE AMSCO CENTURY GRAVITY AND PREVACUUM STERILIZERS OPERATOR MANUAL (P129367-408). (TABLE 3-2. 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 CENTURY GRAVITY AND PREVACUUM STERILIZERS OPERATOR MANUAL STATES (3-16), "STEAM GENERATORS ARE HIGHLY SUSCEPTIBLE TO MINERAL SCALING IF THE SUPPLIED WATER HAS ANY LEVEL OF HARNESS. REFER TO THE REQUIRED FEED WATER QUALITY FOR CARBON STEEL STEAM GENERATORS FOR WATER QUALITY REQUIREMENTS." 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 IS LOOKING INTO MAKING THE NECESSARY IMPROVEMENTS TO THEIR INCOMING WATER QUALITY. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED WATER AND STEAM LEAKING FROM THEIR MEDIUM CENTURY STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE VIEW PORT HAD BECOME DAMAGED ALLOWING WATER AND STEAM TO LEAK FROM THE STERILIZER. THE UNIT HAS BEEN REMOVED FROM SERVICE PENDING REPAIRS. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.