AMSCO 600 STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN INSPECTED THE AMSCO 600 STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION AND THE REPORTED EVENT WAS UNABLE TO BE DUPLICATED. THE TECHNICIAN STATED THAT USER FACILITY PERSONNEL WERE UTILIZING STERILIZATION TRAYS THAT WERE WEIGHING 37 POUNDS. THE MAXIMUM WEIGHT OF THE TRAYS SHOULD BE 25 POUNDS. IF THE TRAY IS TOO HEAVY, THE STERILIZER WILL HAVE DIFFICULTY PULLING THE MOISTURE OUT OF THE CHAMBER DURING A PROCESSING CYCLE. THE OPERATOR MANUAL (PG. 5) HAS A RECOMMENDED LOAD (MAXIMUM) OF 25 POUNDS FOR INSTRUMENT TRAYS FOR SPECIFIC CYCLE TYPES, STERILIZATION TEMPERATURES, STERILIZE TIME AND DRY TIME. THE TECHNICIAN ALSO OBSERVED THAT THE STEAM FILTER ASSEMBLY CONNECTED TO THE STERILIZER REQUIRED SERVICE. THE STEAM FILTER ASSEMBLY IS NOT A STERIS DEVICE AND IS SERVICED AND MAINTAINED BY THE USER FACILITY. THE USER FACILITY IS RESPONSIBLE FOR THE SERVICE AND MAINTENANCE OF THE STEAM FILTER ASSEMBLY. THE TECHNICIAN STATED THAT IF THE STEAM FILTERS ARE CLOGGED OR THE STEAM TRAP IS NOT FUNCTIONING PROPERLY, WATER CAN BUILD UP AND GET PULLED INTO THE STERILIZER'S CHAMBER. THE STERIS SERVICE TECHNICIAN DISCUSSED THE REPORTED EVENT WITH USER FACILITY PERSONNEL AND COUNSELED THEM ON THE PROPER USE AND OPERATION OF THE AMSCO 600 STERILIZER, SPECIFICALLY UTILIZING THE TRAY WEIGHT AND SERVICE NEEDED FOR THE STEAM FILTER ASSEMBLY. THE STERIS SERVICE TECHNICIAN RETURNED THE AMSCO 600 STERILIZER TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT WATER WAS REMAINING IN THE INSTRUMENT TRAYS AFTER BEING PROCESSED IN THEIR AMSCO 600 STERILIZER. PROCEDURE DELAYS AND A PROCEDURE CANCELLATION WERE REPORTED. NO REPORT OF INJURY.