STERRAD® 100NX STERILIZER 1-DR W/ DUO

Description of Event or Problem

A CUSTOMER REPORTED AN EVENT OF AN ¿ODOR¿ OR SMELL EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A HEALTH CARE WORKER (HCW) EXPERIENCED A HEADACHE. IT WAS REPORTED THAT ¿THE HEADACHE PASSED WITHIN A MOMENT,¿ AND THE HCW DID NOT REQUIRE TREATMENT. THE CUSTOMER WAS INSTRUCTED TO POWER OFF THE UNIT AND DISCONTINUE USE. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE REPORTED SYMPTOM WAS DEEMED TO BE MINOR SINCE IT RESOLVED WITHOUT TREATMENT; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE AND FOUND THAT THE UNIT HAD BEEN SERVICED BY A THIRD-PARTY BIOMED WHO HAD INSTALLED NON-ASP PARTS. THE FSE RECOMMENDED A MAINTENANCE SERVICE TO RESTORE THE STERRAD® 100NX TO MANUFACTURER SPECIFICATIONS; HOWEVER, THE CUSTOMER DECLINED THE SERVICE. THE CUSTOMER WAS INFORMED THAT THE UNIT DID NOT MEET SPECIFICATIONS DUE TO THE NON-ASP PART USAGE AND WAS ADVISED TO AVOID USING THE UNIT UNTIL IT IS IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE ODOR/SMELLS 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 ODOR/SMELLS 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." NON-ASP PARTS WERE IDENTIFIED, AND THE CUSTOMER HAS DECLINED ADDITIONAL SERVICES; THEREFORE, NO FURTHER ANALYSIS WILL BE COMPLETED. THE ASSIGNABLE CAUSE OF THE ODOR/SMELL COULD NOT BE VERIFIED, BUT IS LIKELY DUE TO THE CATALYTIC CONVERTER, OIL MIST FILTER, AND VACUUM PUMP OIL. THE FIELD SERVICE ENGINEER RECOMMENDED A MAINTENANCE SERVICE TO REPLACE THE PARTS; HOWEVER, THE CUSTOMER DECLINED THE SERVICE AND THE SYSTEM WAS NOT RESTORED TO MANUFACTURER SPECIFICATIONS. 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 #: (B)(4).