SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM

Additional Manufacturer Narrative

A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE UNIT; HOWEVER, THE INSPECTION COULD NOT BE PERFORMED AS THE USER FACILITY ADVISED THE TECHNICIAN THEY WERE CONDUCTING THEIR OWN INTERNAL INVESTIGATION. THE USER FACILITY'S INSURANCE PROVIDER DID PROVIDE PHOTOGRAPHS OF THE UNIT, WHICH REVEALED DAMAGE WITHIN THE FILTER B ASSEMBLY OF THE DUAL PREFILTER SYSTEM. SPECIFICALLY, THE HOUSING HAD SEPARATED AT THE SUMP INTERFACE, CREATING AN OPENING THAT ALLOWED WATER TO ESCAPE FROM THE FILTER HOUSING. THE OBSERVED STRESS MARKINGS TO THE HOUSING ARE CONSISTENT WITH IMPROPER LOADING OF THE FILTERS BY USER FACILITY PERSONNEL DURING ROUTINE MAINTENANCE. THE SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM INSTRUCTIONS FOR USE (IFU) STATES, "REMOVAL AND REPLACEMENT OF FILTERS A AND B, INCLUDING THE ASSOCIATED HOUSINGS, ARE PERFORMED BY THE CUSTOMER AS PART OF ROUTINE MAINTENANCE PROCEDURES." THE SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM IS APPROXIMATELY 15 YEARS OLD AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR PREVENTIVE MAINTENANCE ACTIVITIES. THE USER FACILITY IS RESPONSIBLE FOR ALL MAINTENANCE ACTIVITIES. THE USER FACILITY HAS ELECTED TO REPLACE THEIR SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM. STERIS CONDUCTED COUNSELING WITH USER FACILITY ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM, SPECIFICALLY THE IMPORTANCE OF PROPER ROUTINE MAINTENANCE OF THE FILTER SYSTEMS. A 3-YEAR COMPLAINT REVIEW HAS CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. 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.

Description of Event or Problem

THE USER FACILITY'S INSURANCE PROVIDER REPORTED THAT THEIR SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM LEAKED WATER ONTO THE FLOOR. NO REPORT OF INJURY.