STERRAD 100S STERILIZER

Additional Manufacturer Narrative

E1. INITIAL REPORTER PHONE NUMBER: (B)(6) THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND TIGHTENED THE OIL MIST FILTER SCREW TO RESOLVE THE REPORTED ISSUE. THE FSE COMPLETED SUCCESSFUL TESTS AND CONFIRMED THAT THE UNIT MET SPECIFICATIONS. THE SYSTEM WAS RETURNED TO SERVICE. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING ANALYSIS OF THE SMOKE/OIL MIST ISSUE, SYSTEM RISK ANALYSIS (SRA), AND FUNCTIONAL 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 SMOKE/OIL MIST ISSUE FOR THE STERRAD® 100S UNIT WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM OPEN 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, SO PRODUCT EVALUATION WAS NOT PERFORMED. ASSIGNABLE CAUSE: THE OIL MIST FILTER SCREW NEEDING TO BE TIGHTENED MAY BE THE MOST LIKELY ASSIGNABLE CAUSE OF THIS COMPLAINT. 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 #: (B)(4)

Description of Event or Problem

IT WAS REPORTED FROM A HOSPITAL IN (B)(6), A FEMALE HEALTH CARE WORKER (HCW) WITH A HISTORY OF ASTHMA EXPERIENCED A RESPIRATORY REACTION AND SOUGHT EMERGENCY CARE RELATED TO OIL MIST FROM A STERRAD 100S STERILIZER. REGARDING THIS EVENT, PREVIOUS CYCLES WERE RUN, THEN A SHORT CYCLE STARTED AND THE HCW LEFT THE ROOM, AND THE DOOR WAS CLOSED. UPON RETURN IT WAS NOTED THAT OIL MIST HAD FILLED THE ROOM. CLINICAL DETAILS WERE PROVIDED BY THE OCCUPATIONAL HEALTH PHYSICIAN, WHO REPORTED THE HCW EXPERIENCED SHORTNESS OF BREATH AND WAS EVALUATED IN THE EMERGENCY DEPARTMENT WHERE SHE RECEIVED THE FOLLOWING TREATMENT: SUBCUTANEOUS ADRENALINE, OXYGEN VIA NASAL CANNULA, IV MEDICATION AND INHALATION THERAPY (SPECIFIC NAMES OF MEDICATION NOT KNOWN). LASTLY, IT WAS REPORTED SHE IS WELL, WITH NO COMPLICATIONS, AND SHE CONTINUES TO WORK IN THE DEPARTMENT WITH THE STERRAD UNIT. REGARDING THE ROOM WHERE THE STERILIZER IS LOCATED, IT WAS REPORTED THAT IT IS SMALL, AND ISOLATED WHEN THE DOOR IS CLOSED AND NOT WELL VENTILATED. THERE ARE NO WINDOWS, ONLY AIR CONDITIONING. AIR EXCHANGES HAVE NOT BEEN MEASURED. THIS COMPLAINT IS DEEMED REPORTABLE AS A SERIOUS INJURY. THE HCW RECEIVED MEDICATION TO TREAT HER RESPIRATORY SYMPTOMS. HOWEVER, THE STERRAD 100S USER GUIDE WARNS THAT OIL MIST EXPOSURE MAY, THEORETICALLY, POSE AN INCREASED RISK TO PEOPLE WITH CERTAIN RESPIRATORY CONDITIONS, SUCH AS ASTHMA, AND THEY SHOULD TAKE SPECIAL PRECAUTIONS NOT TO BE EXPOSED TO THE MIST.