20" CENTURY STERILIZER

Additional Manufacturer Narrative

THE TECHNICIAN COLLECTED WATER SAMPLES TO BE TESTED. THE RESULTS IDENTIFIED THAT ONE OF THE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE REQUIREMENTS FOR THE ELECTRIC STEAM GENERATOR AS STATED IN THE AMSCO CENTURY STERILIZER OPERATOR MANUAL (TABLE 3-2. REQUIRED FEED WATER QUALITY FOR CARBON-STEEL STEAM GENERATORS). 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

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 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 20" CENTURY STERILIZER. THE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE VIEW PORT WAS DAMAGED. AS THE VIEWPORT WAS DAMAGED IT ALLOWED STEAM AND WATER TO LEAK INTO THE CHAMBER OF THE UNIT SUBSEQUENTLY CAUSING THE REPORTED EVENT TO OCCUR. THE TECHNICIAN REPAIRED THE UNIT, TESTED THE FUNCTION AND OPERATION, AND RETURNED THE STERILIZER TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A "BURN" AFTER COMING INTO CONTACT WITH STEAM FROM THEIR 20" CENTURY STERILIZER. THE EMPLOYEE WENT TO THE FACILITY'S EMERGENCY ROOM; IT IS UNKNOWN THE TYPE OF TREATMENT THAT MAY HAVE BEEN ADMINISTERED.