BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 3171229 · Received June 14, 2013

    Report

    Report Number
    2084725-2013-00263
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 30, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-0744-0746-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 (PM1) WAS PERFORMED AND THE VACUUM PUMP WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. ADDITIONAL MANUFACTURER NARRATIVE / CORRECTED DATA: ADDITIONAL PART REPLACED DURING SERVICE: VACUUM CONTROL VALVE. CONCLUSION: BASED ON CAPA INVESTIGATION AND ASTM TESTING, OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD SYSTEMS. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS (FMEA), AND SYSTEM HAZARD AND USER MISUSE ANALYSIS (SHUMA), AND CORRECTIVE AND PREVENTATIVE ACTION (CAPA). THE DHR WAS REVIEWED. THE UNIT MET MANUFACTURING SPECIFICATIONS AT THE TIME OF RELEASE AND THERE WERE NO ISSUES RELATED TO THIS FAILURE MODE NOTED. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST SIX MONTHS (12/01/2012 THROUGH 05/30/2013) DID NOT OBSERVE ANY SIGNIFICANT TREND. THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND REVEALED A SIGNIFICANT TREND WHICH IS ADDRESSED IN CAPA. THE FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) SCORES ARE BELOW 100 AND IS CONSIDERED ACCEPTABLE. THE SHUMA INDICATES THE RISK IS BROADLY ACCEPTABLE FOR MODERATE LEVEL INJURY AND AS LOW AS REASONABLY PRACTICABLE FOR MILD (LIMITED) EXPOSURE TO ODOR OR ODORANTS. CAPA INVESTIGATION AS WELL AS THE ASTM TESTING PERFORMED INDICATED OIL DEGRADATION CAN CAUSE ODOR/SMELLS FOR STERRAD® SYSTEMS. THE VACUUM PUMP WAS RETURNED AND TESTED. THE VACUUM PUMP WAS UNABLE TO PASS A PUMP DOWN TEST AND WAS EMITTING ODORS. THE REASON FOR RETURN OF THE VACUUM PUMP WAS CONFIRMED. THE VACUUM CONTROL VALVE WAS RETURNED AND TESTED. THE VACUUM CONTROL VALVE PASSED A TEST CYLE WITH NO IRREGULAR ODORS. THE REASON FOR RETURN OF THE VACUUM CONTROL VALVE WAS NOT CONFIRMED. THE REPORTED ISSUE WAS 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 "SMELL" (ODOR) EMITTING FROM THE STERRAD NX STERILIZER. THERE WAS NO REPORT OF ANY HUMAN REACTION. THE CUSTOMER WAS ADVISED TO TURN THE UNIT OFF AND LEAVE 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
    271825 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1