STERRAD® 100S STERILIZER

Description of Event or Problem

WHILE AT CUSTOMER SITE FOR A SEPARATE ISSUE, THE FIELD SERVICE ENGINEER REPORTED AN EVENT OF AN ¿OILY SMELL¿ OR ODOR EMITTING FROM THE STERRAD® 100S STERILIZER. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A PREVIOUS SERIOUS INJURY.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE OIL WAS LOW FOR THE VACUUM PUMP; HOWEVER, THE CUSTOMER HAS DECLINED FURTHER SERVICES AND THE UNIT WAS NOT RETURNED TO SPECIFICATIONS. THE CUSTOMER WAS RECOMMENDED TO AVOID USING THE UNIT UNTIL IT IS IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. 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).

Additional Manufacturer Narrative

H3: 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® 100S 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 SINCE THE CUSTOMER HAS DECLINED FURTHER SERVICES. THE ASSIGNABLE CAUSE OF THE ODOR/SMELL IS LIKELY DUE TO THE VACUUM PUMP OIL. THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE OIL WAS LOW; HOWEVER, THE CUSTOMER HAS DECLINED FURTHER SERVICES AND THE UNIT WAS NOT RETURNED TO SPECIFICATIONS. THE CUSTOMER WAS RECOMMENDED TO AVOID USING THE UNIT UNTIL IT IS IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: (B)(4).