V-PRO

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROCESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN AFTER UNLOADING THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Description of Event or Problem

THE USER FACILITY REPORTED THAT TWO EMPLOYEES OBTAINED A BURN AFTER UNLOADING THEIR V-PRO MAX 2 STERILIZER. IT IS UNKNOWN IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE UNIT AND FOUND THAT THE SV4 VALVE REQUIRED REPLACEMENT. AS DESIGNED, THE STERILIZER HAD ALARMED AND ABORTED THE CYCLE. TO RESOLVE THE ISSUE, THE TECHNICIAN REPLACED THE SV4 VALVE. THE UNIT WAS TESTED, CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION, AND RETURNED TO SERVICE. WHILE ONSITE, THE TECHNICIAN WAS INFORMED THAT NEITHER OF THE EMPLOYEES WERE NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE HANDLING INSTRUMENTS AFTER THE ABORTED CYCLE. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES, "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI GUIDELINES) WEARING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE OPERATOR MANUAL FURTHER 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 UNIT IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES; THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. WHILE ONSITE THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE V-PRO MAX 2 STERILIZER, SPECIFICALLY ON WEARING APPROPRIATE PPE WHEN AN ABORTED CYCLE OCCURS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.