BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 2972492 · Received February 21, 2013

    Report

    Report Number
    2084725-2013-00074
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    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 (JULY 2012 THROUGH JANUARY 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 CATALYTIC CONVERTER WAS RETURNED AND TESTED. THE CATALYTIC CONVERTER PASSED A PUMP DOWN TEST AND EXHIBITED NO ODOR. THE REASON FOR RETURN OF THE CATALYTIC CONVERTER WAS NOT CONFIRMED. THE OIL MIST FILTER WAS RETURNED AND TESTED. THE OIL MIST FILTER PASSED A PUMP DOWN TEST AND HAD NO ODOR DETECTED. THE REASON FOR RETURN OF THE OIL MIST FILTER WAS NOT CONFIRMED. THE VACUUM PUMP WAS RETURNED AND TESTED. THE VACUUM PUMP WAS UNABLE TO PASS A PUMP DOWN TEST AND THERE WAS AN ODOR DETECTED. THE REASON FOR RETURN OF THE VACUUM PUMP WAS 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 "STRONG ODOR" EMITTING FROM THE STERRAD NX STERILIZER. THERE WAS NO REPORT OF HUMAN REACTION. 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) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75956 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1