AMSCO

Additional Manufacturer Narrative

USER FACILITY MAINTENANCE HAS INSTALLED A WATER PRESSURE REGULATOR TO ENSURE PROPER INCOMING WATER PRESSURE TO THE AMSCO 400 STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT AND FOUND A BOLT THAT SECURED THE CK5 VALVE BROKE, ALLOWING FOR WATER TO LEAK FROM THE STERILIZER'S PIPING. UPON FURTHER INSPECTION, THE TECHNICIAN FOUND THAT THE FACILITY WATER PRESSURE THAT ENTERED THE STERILIZER WAS OVER 100 PSIG, ABOVE THE MAXIMUM REQUIREMENT, WHICH CAUSED THE BOLT TO BREAK AND RESULTED IN THE REPORTED EVENT. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE BOLT AND REPAIRED THE CK5 VALVE, TESTED THE UNIT, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED IT TO SERVICE. THE AMSCO 400 SERIES SMALL STEAM STERILIZERS OPERATOR MANUAL STATES, "SECTION 3-1 WATER PRESSURE: THE WATER EJECTOR SPECIFICATION IS 2.1 TO 3.5 BAR (30 TO 50 PSIG), DYNAMIC. THE SUPPLIED WATER PRESSURE MUST BE WITHIN THE SPECIFICATIONS INDICATED IN THE EQUIPMENT DIAGRAM. IF THE PRESSURE IS TOO HIGH, A REGULATOR WILL NEED TO BE INSTALLED. IF THE WATER PRESSURE IS TOO LOW, THE EQUIPMENT'S PERFORMANCE WILL BE AFFECTED". WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER WATER PRESSURE REQUIREMENTS WITH THEIR AMSCO 400 STERILIZER. THE USER FACILITY HAS COMMITTED TO MAKING THE NECESSARY IMPROVEMENTS TO THEIR WATER PRESSURE. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED A WATER LEAK FROM THEIR AMSCO 400 STERILIZER. NO REPORT OF INJURY.