AMSCO

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER LEAKING WATER ONTO THE FLOOR. NO REPORT OF INJURY.

Additional Manufacturer Narrative

INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT WATER WAS LEAKING FROM THE VIEWPORT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE VIEWPORT. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED 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 FOR THE FACILITY'S COLLECTED WATER SAMPLES IDENTIFIED THAT SIX 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

CONTRARY TO REPORT (3005899764-2025-00026-01), THE RESULTS FOR THE FACILITY'S COLLECTED WATER SAMPLES IDENTIFIED THREE CRITICAL CHEMICAL ATTRIBUTES OF WATER QUALITY WERE ABOVE THE MAXIMUM REQUIREMENTS INSTEAD OF THE PREVIOUSLY STATED SIX. THIS WAS A TYPOGRAPHICAL ERROR.