BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 3191640 · Received June 26, 2013

    Report

    Report Number
    2084725-2013-00288
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Removal / Correction Number
    Z-1026-1027-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS NOT CONFIRMED. THE OIL MIST FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: 03/12/2010. 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 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 (12/22/2012 TO 06/20/2013) 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 TRENDING FOR PROBLEM CODE EYE REACTION (JANUARY 2013 THROUGH DECEMBER 2013) REVEALED THE HIGHEST RISK IS CONSIDERED BROADLY ACCEPTABLE. THE TRENDING FOR PROBLEM CODE HUMAN REACTION (JANUARY 2013 THROUGH DECEMBER 2013) REVEALED THE HIGHEST RISK IS CONSIDERED BROADLY ACCEPTABLE. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER SCORES ARE BELOW (B)(4) AND ARE CONSIDERED ACCEPTABLE. 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) SHOWS THAT THE RISK IS AS LOW AS REASONABLY PRACTICAL 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® 100NX OIL MIST FILTER CAUSED OIL VAPOR EMISSIONS THAT EXACERBATED THE ODOR/SMELL COMPLAINTS REPORTED FOR THE STERRAD® 100NX SYSTEM; THE USE OF A LESS OXIDATIVELY STABLE VACUUM PUMP OIL CAUSED THE ODOR/SMELLS FOR THE STERRAD® 100NX SYSTEM. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF AN ODOR EMITTING FROM THE STERRAD 100NX STERILIZER. TWO HEALTHCARE WORKERS (HCWS) REPORTED HUMAN REACTIONS. ONE HCW EXPERIENCED BURNING EYES, NAUSEA, HEADACHE AND DIZZINESS. THE SECOND HCW EXPERIENCED WATERY EYES AND A HEADACHE. NEITHER HCW RECEIVED MEDICAL ATTENTION/TREATMENT AND BOTH ARE REPORTED TO BE "NORMAL." THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND VACATE THE AREA. AN ASP FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290125 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1