BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1299377 · Received December 11, 2008

    Report

    Report Number
    2084725-2008-00804
    Event Type
    Malfunction
    Date Received
    December 11, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Removal / Correction Number
    Z-1632-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OIL MIST. CAPITAL EQUIPMENT, EVALUATED AT CUSTOMER SITE. THE FSE REPORTED THE FOLLOWING: DIAGNOSED THE STERRAD NX UNIT EMITTING OIL MIST. THE FSE REPLACED THE OIL FILL CAPS ON THE VACUUM PUMP THEN PERFORMED THE VACUUM/PLASMA TEST PROCEDURE, THE VACUUM LEAK TEST, AND THE TEMPERATURE VERIFICATION PROCEDURE. AN EMPTY CHAMBER TEST CYCLE WAS ALSO COMPLETED. CONCLUSION: ASP ASSESSMENT: THE VACUUM PUMP WAS NOT RETURNED ON THIS COMPLAINT. THE FSE PERFORMED A VISUAL EXAMINATION OF THE PUMP AND DETERMINED THAT THE OIL MIST/HAZE WAS EMANATING FROM THE OIL FILL PLUGS. SEE ATTACHED PICTURES OF EXAMPLES OF THIS DEGRADATION. A CHANGE ORDER (CO) WAS INITIATED TO CHANGE THE DESIGN OF THE VACUUM PUMP TO HAVE STAINLESS STEEL OIL FILL PLUGS AS OPPOSED TO OIL FILL PLUGS MADE FROM NYLON. THE FMEA WAS REVIEWED AND UPDATED FOR THIS ISSUE. THE CO MITIGATED THE RPN NUMBER TO AN ACCEPTABLE LEVEL. A HEALTH HAZARD EVALUATION WAS ALSO PERFORMED AND HAD A NEGLIGIBLE RISK. THE DHR FOR THE STERRAD NX (B)(4) WAS REVIEWED, THERE WERE NO ISSUES RELATED TO THIS FAILURE MODE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED OIL MIST AND HAZE WAS COMING FROM THE UNIT. THE CUSTOMER STOPPED THE CYCLE AND NOTICED THE HAZE ALSO STOPPED. THERE WERE NO HUMAN REACTIONS TO THE HAZE. THE ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA