inforMED
MalfunctionMLR

V-PRO MAX 2 STERILIZER

Received Jan 5, 2024 · Event occurred Dec 7, 2023

Report 3005899764-2024-00002 · MDR key 18460623

Device

Generic name

Sterilizer

Product problems

  • Use of Device Problem
  • Use of Device Problem

Patient

Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL ON THE IMPORTANCE OF WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THEIR V-PRO MAX 2 STERILIZER.

Description of Event or Problem

THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN WHILE REMOVING A PROCESSED PACK FROM A V-PRO MAX 2 STERILIZER AFTER A COMPLETED CYCLE. THE EMPLOYEE WAS TAKEN TO THE EMERGENCY ROOM AND RECEIVED MEDICAL TREATMENT (OINTMENT).

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE STERILIZER AND FOUND THE UNIT TO BE OPERATING PROPERLY. NO ISSUES WITH THE FUNCTION OR THE OPERATION OF THE STERILIZER WERE IDENTIFIED, AND THE STERILIZER WAS RETURNED TO SERVICE. THE TECHNICIAN WAS INFORMED THAT THE EMPLOYEE WAS NOT WEARING PROPER PPE, SPECIFICALLY GLOVES, WHILE OPERATING THE STERILIZER AS STATED IN THE OPERATOR MANUAL. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES (6-24), "STERIS RECOMMENDS (IN ACCORDANCE WITH ANSI/AAMI ST58, 2013) WEARING CHEMICAL-RESISTANT GLOVES WHEN USING THE STERILIZATION UNIT." THE OPERATOR MANUAL FURTHER STATES (1-2), "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." ADDITIONALLY, USER FACILITY PERSONNEL SHOULD ENSURE ALL INSTRUMENTS ARE PROPERLY DRY PRIOR TO PLACEMENT IN THE V-PRO MAX 2 STERILIZER. THE V-PRO MAX 2 STERILIZER OPERATOR MANUAL STATES (A-1), "A. DRY ALL ITEMS THOROUGHLY. B. ENSURE ALL MOISTURE IS REMOVED FROM ALL INTERNAL PARTS (INCLUDING LUMENS). IF NOT, RESIDUAL HYDROGEN PEROXIDE MAY REMAIN AT CYCLE COMPLETION." AN ACCOUNT MANAGER WILL OFFER USER FACILITY PERSONNEL IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE V-PRO MAX 2 STERILIZER, SPECIFICALLY WEARING PROPER PPE AND PROPERLY DRYING INSTRUMENTS BEFORE PROCESSING. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.