AMSCO V-PRO

Additional Manufacturer Narrative

STERIS HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE TWO EMPLOYEES SUBJECT OF THE REPORTED EVENT; HOWEVER, THE USER FACILITY HAS NOT RESPONDED. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE V-PRO MAX STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE FUNCTION OR OPERATION OF THE UNIT AND THE STERILIZER WAS RETURNED TO SERVICE. THE V-PRO MAX STERILIZER OPERATOR MANUAL 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 OPERATOR MANUAL FURTHER STATES, "ANSI/AAMI ST58, 2013, RECOMMENDS USING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED BURNS WHILE REMOVING VAPROX HC STERILANT CUPS FROM THEIR V-PRO MAX STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.