BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 3023285 · Received March 27, 2013

    Report

    Report Number
    2084725-2013-00139
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 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
    CA
    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.

    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.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: 02/09/2005. 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 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 ((B)(4) 2012 THROUGH (B)(4) 2013) DID NOT OBSERVE ANY SIGNIFICANT TREND. THE TREND FOR THE PRODUCT MALFUNCTION CODE OF ODOR/SMELLS WAS COMPLETED FROM (B)(4) 2013 THROUGH (B)(4) 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 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. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. 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

    AN INTERNATIONAL CUSTOMER REPORTED AN EVENT OF AN ODOR EMITTING FROM THE STERRAD NX STERILIZER. A FIELD SERVICE ENGINEER WAS DISPATCHED TO ASSESS THE UNIT ONSITE. MULTIPLE ATTEMPTS TO GATHER FURTHER INFORMATION FOR POTENTIAL HUMAN REACTIONS HAVE BEEN UNSUCCESSFUL. ASP WILL CONTINUE TO FOLLOW UP. SHOULD ADDITIONAL INFORMATION BE RECEIVED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125109 STERRAD NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 10033050049

    Patients

    Seq Age Sex Outcome Treatment
    1