BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 3040627 · Received April 8, 2013

    Report

    Report Number
    2084725-2013-00164
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PREVENTATIVE MAINTENANCE (PM2) WAS PERFORMED AND THE CATALYTIC DECOMP FILTER AND VACUUM PUMP OIL WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATE: AUGUST 18, 2011. 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 REGARDING 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 ((B)(4) 2012 TO (B)(4) 2013) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM (B)(4) 2013 THROUGH (B)(4) 2013 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. THE TREND OF THE PRODUCT MALFUNCTION CODE HUMAN REACTION WAS COMPLETED FROM (B)(4) 2013 THROUGH DECEMBER 2013 AND REVEALED THE RISK ACCEPTABILITY FOR THE PAST 12 MONTHS TO BE "BROADLY ACCEPTABLE." THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER SCORES ARE BELOW 100 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 DOCUMENTED OR REPORTED IN CLINICAL PRACTICE, 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: 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. THE FIELD SERVICE ENGINEER REPLACED PARTS FROM A PM KIT (WHICH INCLUDES THE CATALYTIC CONVERTER, AND VACUUM PUMP OIL). THE UNIT WAS LEFT IN WORKING ORDER. THE PARTS WERE NOT RETURNED FOR INVESTIGATION. THE ISSUE HAS BEEN RESOLVED AT THE CUSTOMER FACILITY. THE ISSUE WILL BE TRACKED AND TRENDED. NO FURTHER INVESTIGATION IS NECESSARY AT THIS TIME.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A "PLUME OF WHITE SMOKE AND A SMELL OF PEROXIDE" (ODOR) EMITTING FROM THE STERRAD 100NX STERILIZER AT THE END OF A CYCLE. ONE HCW REPORTED A REACTION OF AN "IRRITATED THROAT" LASTING 45 MINUTES. THE HCW DID NOT RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND IS REPORTED TO BE "GOOD." 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 FROM AN ODOR DATED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143726 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1