AMSCO 400 STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND THAT THE VIEW PORT HAD BECOME DAMAGED ALLOWING WATER TO LEAK FROM THE STERILIZER. THE TECHNICIAN REPLACED THE VIEW PORT, 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 TO ENSURE THAT THEIR INCOMING WATER SUPPLY REMAINS WITHIN THE UNIT'S OPERATING REQUIREMENTS. THE RESULTS ARE STILL PENDING. A FOLLOW-UP MDR SHALL BE SUBMITTED WHEN THE RESULTS BECOME AVAILABLE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED WATER WAS LEAKING FROM THEIR AMSCO 400 STERILIZER ONTO THE FLOOR. NO REPORT OF INJURY OR PROCEDURE DELAY.

Additional Manufacturer Narrative

RESULTS FOR THE FACILITY'S COLLECTED WATER SAMPLES IDENTIFIED THAT FOUR 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 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.