AMSCO 400 STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN INSPECTED THE STERILIZER AND FOUND THE S1 VALVE WAS NOT OPERATING PROPERLY. AS DESIGNED, THE UNIT ALARMED AS THE VALVE WAS NOT OPERATING PROPERLY. IT HAS BEEN REPORTED THAT THE EMPLOYEE DID NOT FOLLOW PROPER OPERATING PROCEDURES FOR THE STERILIZER ALARM AS THEY FORCED THE STERILIZER DOOR OPEN INSTEAD OF CONTACTING SERVICE STATED IN THE OPERATOR MANUAL. ADDITIONALLY, THE USER WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES. THE AMSCO 400 OPERATOR MANUAL STATES (9.2.9) "ALARM TOO LONG IN EXHAUST- OPERATOR INSTRUCTIONS, 1. SILENCE ALARM. 2. IF ALARM RECURS, CALL SERVICE." THE AMSCO 400 OPERATOR MANUAL STATES (1-2), "WARNING - BURN HAZARD: STERILIZER, RACK/SHELVES WILL BE HOT AFTER CYCLE IS RUN. ALWAYS WEAR PROTECTIVE GLOVES AND APRON WHEN REMOVING A PROCESSED LOAD. PROTECTIVE GLOVES AND APRON MUST BE WORN WHEN RELOADING STERILIZER FOLLOWING THE PREVIOUS OPERATION." THE TECHNICIAN REPLACED THE S1 VALVE, TESTED THE UNIT, CONFIRMED IT TO BE OPERATIONAL, AND RETURNED IT TO SERVICE. THE STERIS SERVICE TECHNICIAN COUNSELED THE USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR AMSCO 400 STERILIZER ALARMED TOO LONG IN EXHAUST DURING A CYCLE AND FOLLOWING THAT ALARM, A FACILITY PERSONNEL OBTAINED A BURN ON THEIR HAND WHILE OPENING THE DOOR. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.