BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200, SINGLE DOOR

    MDR report key: 2864987 · Received December 10, 2012

    Report

    Report Number
    2084725-2012-00108
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1026-1027-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    USAGE OF DEVICE: CORRECTED FROM UNKNOWN TO REUSE. CONCLUSION: ROOT CAUSE IDENTIFIED IN CAPA WAS FOUND TO BE PREMATURE FAILURE/SATURATED OIL MIST FILTER OR VACUUM PUMP OIL. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS, HEALTH HAZARD EVALUATION, SYSTEM HAZARD AND USER MISUSE ANALYSIS, AND CAPA. ¿ THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND NO ISSUES RELATING TO THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. ¿ THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST 6 MONTHS (MAY 2012 TO NOVEMBER 2012) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. ¿ THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. ¿ THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER FOR THIS FAILURE MODE IS 128 WHICH IS GREATER THAN THE ACCEPTABLE LIMIT. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. ¿ THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE RISK OF ODOR AND SMELL EXPOSURE. THE SEVERITY AND OCCURRENCE FOR THE GENERAL POPULATION WERE LIMITED (TRANSIENT, MINOR IMPAIRMENT, NO MEDICAL TREATMENT REQUIRED) AND THE PRODUCT PROBLEM HAS BEEN KNOWN TO RESULT IN THE IDENTIFIED HARM, BUT ONLY OCCASIONALLY AND/OR UNDER UNUSUAL CIRCUMSTANCES. ¿ THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) DETERMINED THE RISK IS AS LOW AS REASONABLY PRACTICABLE FOR EXPOSURE TO ODOR OR ODORANTS. ¿ THE CAPA (CORRECTIVE AND PREVENTATIVE ACTION) IDENTIFIED THE ROOT CAUSE FOR THE ODOR/SMELLS ISSUE AS: (1) PREMATURE FAILURE OF THE USED AND SATURATED STERRAD® 200 OIL MIST FILTER CAUSED OIL VAPOR EMISSIONS THAT EXACERBATED THE ODOR/SMELL COMPLAINTS REPORTED FOR THE STERRAD® 200 SYSTEM. (2) THE USE OF A LESS OXIDATIVELY STABLE VACUUM PUMP OIL CAUSED THE ODOR/SMELLS FOR THE STERRAD® 200 SYSTEM. THE ASP FIELD SERVICE ENGINEER (FSE) REPLACED THE VACUUM PUMP AND THE UNIT WAS LEFT IN WORKING ORDER. IN ADDITION, AN ASP TEAM COMPROMISED OF QUALITY, RESEARCH AND DEVELOPMENT, AND FIELD SERVICE VISITED THE CUSTOMER SITE. IT WAS DISCOVERED THE VENTILATION IN THE ROOM WAS INADEQUATE TO ASP'S SPECIFICATIONS OF 10 AIR EXCHANGES PER HOUR. THE ROOM CONDITIONS ALSO PROPAGATED AN UNCOMFORTABLE INCREASE IN TEMPERATURE AND HUMIDITY. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Additional Manufacturer Narrative · 1

    NI

    Description of Event or Problem · 1

    A FACILITY REPORTED A STRONG "VINEGARY-LIKE" ODOR OR "CRAYON SMELL" COMING FROM THE STERRAD 200 UNIT. THE MANAGER OF THE DEPARTMENT STATED "THE FUMES/VAPOR HAS A VERY DISTINCT ODOR. IT WILL FILL THE ENTIRE ROOM [AND THE DEPARTMENT IS VERY LARGE]. THERE ARE TIMES IT [THE ODOR] CAN TAKE YOUR BREATH AWAY AND MAKE YOU FEEL AS IF YOUR THROAT IS CLOSING OFF." THE MANAGER OF STERILE PROCESSING STATED THAT HCWS ARE EXPERIENCING SYMPTOMS RELATED TO THE ODOR/SMELL. AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THE FSE DID NOT SMELL THE ODOR AND INSTRUCTED THE CUSTOMER TO RUN A FEW CYCLES AND SEE IF THE ALLEGED ODOR WOULD GO AWAY. AFTER SERVICE THEY CONTINUE TO EXPERIENCE AN ODOR EMITTING FROM THE STERRAD 200 SYSTEM. THE CUSTOMER WAS INSTRUCTED TO TAKE THE UNIT OUT OF PRODUCTION UNTIL THE FSE CAN ASSESS THE UNIT. THE HCWS ARE STILL EXPERIENCING SYMPTOMS. IN THE EVENT ASP RECEIVES ADDITIONAL INFORMATION A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2012. RELATED COMPLAINTS: (B)(4). THIS IS FIVE OF FIVE 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2012-00104; 2084725-2012-00105; 2084725-2012-00106; 2084725-2012-00107 AND 2084725-2012-00108.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 200, SINGLE DOOR STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1