V-PRO MAX STERILIZER

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE V-PRO MAX STERILIZER AND CONFIRMED THAT THE UNIT HAD ALARMED DUE TO A TEMPERATURE DEVIATION BETWEEN RTD1 AND RTD2, TEMP PROBE VAPORIZER. THE RESISTANCE TEMPERATURE DETECTOR (RTD) MEASURES THE TEMPERATE THAT THE UNIT IS REACHING. WHEN OUT OF CALIBRATION, THE TEMPERATURE DEVIATION ALARM CAN OCCUR. WHILE ONSITE, THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE SUBJECT OF THE EVENT WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE V-PRO MAX STERILIZER. THE V-PRO MAX STERILIZER OPERATOR MANUAL (1-2) STATES, "DANGER - CHEMICAL INJURY HAZARD: ANY VISIBLE LIQUIDS IN THE CHAMBER OR ON THE LOAD MUST BE TREATED AS CONCENTRATED HYDROGEN PEROXIDE. OBSERVE ALL HYDROGEN PEROXIDE HANDLING PRECAUTIONS. WHEN HANDLING HYDROGEN PEROXIDE, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. THE V-PRO MAX OPERATOR MANUAL (1-2) STATES, "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX STERILIZER. THE V-PRO MAX OPERATOR MANUAL, (A-1) STATES, "DRY ALL ITEMS THOROUGHLY. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION AND/OR A CYCLE ABORT OCCURS. ONLY DRY ITEMS ARE TO BE PLACED IN STERILIZATION UNIT." THE TECHNICIAN CALIBRATED RTD1 AND RTD2, TESTED THE UNIT, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATIONS. THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX STERILIZER AND PROPERLY DRYING INSTRUMENTS PRIOR TO PROCESSING. THE V-PRO MAX STERILIZER WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED

Description of Event or Problem

THE USER FACILITY REPORTED THAT THEIR V-PRO MAX STERILIZER ALARMED "FAILURE READING VAPORIZER TEMPERATURE RTD1 & RTD2". THE EMPLOYEE HANDLING THE ITEMS THAT HAD BEEN PROCESSED IN THE STERILIZER OBTAINED A "BURN" TO THEIR HAND. THE EMPLOYEE RECEIVED MEDICAL TREATMENT AND WAS SENT HOME FROM WORK FOR A FEW DAYS FOLLOWING THE REPORTED EVENT.