AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THAT THE BAFFLE ON THE DRAIN TANK WAS BROKEN AND OBSTRUCTING THE DRAIN HOLE, WHICH CAUSED WATER TO BACK UP WITHIN THE UNIT. THIS RESULTED IN DAMAGED TO THE HEAT EXCHANGER AND SUBSEQUENTLY ALLOWED WATER TO ENTER THE CHAMBER AND THE DOOR SEAL TO BREAK. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE BAFFLE, THE DRAIN TANK, HEAT EXCHANGER, DOOR SEAL AND SAFETY VALVES. THE UNIT WAS TESTED AND CONFIRMED OPERATING ACCORDING TO SPECIFICATIONS AND RETURNED TO SERVICE. THE UNIT SUBJECT OF THE EVENT IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. A 3-YEAR COMPLAINT REVIEW INDICATES THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 600 STERILIZER WAS LEAKING WATER, AND THE UNIT ALARMED "TOO LONG TO EXHAUST" ALARM. NO REPORT OF INJURY.