AMSCO

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THAT THE HEAD OF ONE OF THE BOLTS SECURING THE CK-5 VALVE HAD BROKEN. THE TECHNICIAN FOUND THAT THE USER FACILITY'S WATER PRESSURE WAS HIGHER THAN NORMAL WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DAMAGED TO THE CK-5 VALVE. THE USER FACILITY IS RESPONSIBLE FOR ENSURING THAT THE FACILITY WATER PRESSURE REMAINS WITHIN THE STERILIZER'S OPERATING SPECIFICATIONS. THE AMSCO 400 STERILIZER OPERATOR MANUAL STATES (3-1), "WATER PRESSURE - WATER EJECTOR SPECIFICATION IS 30 TO 50 PSIG (2.1 TO 3.5 BAR), DYNAMIC." THE OPERATOR MANUAL FURTHER STATES (3-1), "WATER PRESSURE SUPPLIED MUST BE WITHIN SPECIFICATIONS AS SHOWN ON THE EQUIPMENT DRAWING. IF PRESSURE IS TOO HIGH, A REGULATOR MUST BE INSTALLED. IF WATER PRESSURE IS TOO LOW, EQUIPMENT PERFORMANCE WILL BE AFFECTED." TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE NECESSARY COMPONENTS AND ADJUSTED THE WATER PRESSURE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

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