STERRAD® 100NX ALLCLEAR STERILIZER 1-DR DUO

Additional Manufacturer Narrative

INITIAL REPORTER PHONE NUMBER: (B)(6). A FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. THE OIL MIST FILTER WAS REPLACED TO RESOLVE THE MIST/HAZE ISSUE. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE. 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).

Description of Event or Problem

A CUSTOMER REPORTED AN EVENT OF A ¿MIST¿ OR HAZE EMITTING FROM THE STERRAD® 100NX STERILIZER, AND A HEALTH CARE WORKER (HCW) EXPERIENCED ITCHY EYES AND ITCHY THROAT. THE HCW LEFT THE ROOM AND THE SYMPTOMS RESOLVED WITHIN AN HOUR. NO MEDICAL TREATMENT WAS RECEIVED, AND IT WAS REPORTED THE HCW ¿FEELS FINE AND IS WORKING NORMALLY¿. THE SYMPTOMS RESOLVED WITHOUT MEDICAL INTERVENTION AND WERE ASSESSED TO BE MINOR; HOWEVER, THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY FOR THE MIST/HAZE ISSUE.

Additional Manufacturer Narrative

H3: ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE MIST, HAZE ISSUE, SYSTEM RISK ANALYSIS (SRA), AND PHOTO ANALYSIS. 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." THE FIELD SERVICE ENGINEER PROVIDED PHOTOS OF THE OIL MIST FILTER AND O-RING FOR FURTHER REVIEW, AND STATED NO ISSUES WERE IDENTIFIED FOR THE PARTS DURING SERVICE. BASED ON THE PHOTO ANALYSIS PERFORMED BY PRODUCT ANALYSIS LAB, IT WAS NOTED THAT THE O-RING APPEARED TO HAVE MANY CUTS, NICKS AND IMPRINTS. THE COMPLAINT WAS CONFIRMED BASED ON THE ANALYSIS OF THE PHOTOS PROVIDED. THE ASSIGNABLE CAUSE OF THE MIST/HAZE IS POTENTIALLY DUE TO THE OIL MIST FILTER AND O-RING. THE ASP FIELD SERVICE ENGINEER REPLACED THE PARTS AND CONFIRMED THE STERRAD® 100NX MET FUNCTIONAL SPECIFICATIONS AFTER SERVICE. THE ISSUE WAS RESOLVED AT THE CUSTOMER FACILITY. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).