V-PRO MAX

Description of Event or Problem

THE USER FACILITY REPORTED THEIR V-PRO MAX STERILIZER CAUGHT FIRE. NO REPORT OF INJURY.

Additional Manufacturer Narrative

INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS; A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE; THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

Additional Manufacturer Narrative

ON MARCH 25, 2025, STERIS WAS CONTACTED BY (B)(6) HOSPITAL ("USER FACILITY") REPORTING THAT THEIR V-PRO MAX STERILIZER ("STERILIZER") CAUGHT FIRE. THE DAMAGE SUSTAINED WAS CONTAINED WITHIN THE STERILIZER. NO REPORT OF INJURY. A STERIS SERVICE TECHNICIAN WAS DISPATCHED TO THE FACILITY AND ARRIVED ONSITE TO INSPECT THE STERILIZER. DURING THE INSPECTION, A LOOSENED TEE-FITTING COMPONENT WAS OBSERVED BELOW THE STERILANT RESERVOIR OF THE UNIT. THE UNIT SUBJECT OF THE REPORTED EVENT WAS RETURNED FOR EVALUATION AND THE INVESTIGATION REVEALED THAT THE SOURCE OF THE FIRE WAS LIKELY ATTRIBUTED TO A HYDROGEN PEROXIDE (VAPROX STERILANT) LEAK FROM THE LOOSENED TEE-FITTING. THE HYDROGEN PEROXIDE LEAKED ONTO THE COMPONENTS BELOW WHICH CAUSED THE REPORTED EVENT TO OCCUR. THE CAUSE OF THE LOOSE FITTING MAY HAVE BEEN DUE TO THE TECHNICIAN NOT PROPERLY TIGHTENING THE FITTING DURING THE PREVIOUS SERVICE VISIT. AS A PREVENTIVE MEASURE, THE TECHNICIAN WAS RETRAINED ON THE PROPER PREVENTIVE MAINTENANCE ACTIVITIES, SPECIFICALLY PROPERLY REPLACING THE TEE AND TIGHTENING THE FITTINGS. THE STERILIZER SUBJECT OF THE REPORTED EVENT WAS MANUFACTURED IN 2014 AND IS APPROXIMATELY 11 YEARS OLD. THE V-PRO MAX STERILIZER IS DESIGNED WITH FLAME-RESISTANT MATERIALS AND IS CERTIFIED BY INTERTEK TO UL 61010-1:2012 3RD ED./CSA C22.2#61010-1-12:2012, 3RD ED. SAFETY REQUIREMENTS FOR ELECTRICAL EQUIPMENT FOR MEASUREMENT, CONTROL AND LABORATORY USE, PART 1, AND UL 61010-2-040:2021, 3RD ED/CSA C22.2#61010-2-040:2021 3RD ED., SAFETY REQUIREMENTS, PART 2-040 - PARTICULAR REQUIREMENTS FOR STERILIZERS AND WASHER-DISINFECTORS USED TO TREAT MEDICAL MATERIALS. THE USER FACILITY PURCHASED A REPLACEMENT STERILIZER. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

Additional Manufacturer Narrative

THE STERIS SERVICE TECHNICIAN ARRIVED ON SITE TO INSPECT THE V-PRO MAX STERILIZER AND DUE TO THE DAMAGE SUSTAINED, WAS UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. IN LIEU OF REPAIRING THE UNIT, THE USER FACILITY RECEIVED A NEW UNIT. THE UNIT SUBJECT OF THE REPORTED EVENT WAS RETURNED TO STERIS FOR FURTHER EVALUATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.