STERRAD® 100NX ALLCLEAR STERILIZER 2-DR

Description of Event or Problem

A CUSTOMER REPORTED AN EVENT OF A ¿SMOKE¿ OR MIST/HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THE CUSTOMER BIOMED WAS PROVIDED REMOTE SUPPORT FOR UNIT ASSESSMENT. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE NUMBER: (B)(6). A SERVICE ENGINEER PROVIDED REMOTE SUPPORT TO THE CUSTOMER BIOMED, AND THE OIL RETURN HOSE/TUBE WAS TIGHTENED TO RESOLVE THE MIST/HAZE ISSUE. THE CUSTOMER BIOMED CONFIRMED THE UNIT WAS RESTORED TO PROPER OPERATIONS. H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE MIST/HAZE ISSUE, AND SYSTEM RISK ANALYSIS (SRA). THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ISSUES RELATING TO THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. TRENDING ANALYSIS OF THE MIST/HAZE ISSUE FOR THE STERRAD® 100NX UNIT WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM THE EVENT DATE, AND NO SIGNIFICANT TREND WAS OBSERVED. REVIEW OF RISK DOCUMENTATION SHOWS THE RISK FOR EXPOSURE TO TOXIC OR CORROSIVE MATERIAL TO BE "LOW." NO PARTS WERE REPLACED IN RESOLVING THIS ISSUE. THE ASSIGNABLE CAUSE OF THE MIST/HAZE IS LIKELY DUE TO THE OIL RETURN HOSE/TUBE. THE CUSTOMER BIOMED TIGHTENED THE PART AND CONFIRMED THE STERRAD® 100NX WAS RESTORED TO PROPER OPERATIONS AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ADVANCED STERILIZATION PRODUCTS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ASP COMPLAINT REF #: CMP (B)(4).