BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2132821 · Received June 17, 2011

    Report

    Report Number
    2084725-2011-00044
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    November 22, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Removal / Correction Number
    Z-1632-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE EFFECT ANALYSIS AND SYSTEM HAZARD USE AND MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD 100NX SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 100NX DID NOT REVEAL A TREND FOR HAZE / OIL MIST FAILURES. TRENDING ANALYSIS FOR HAZE / OIL MIST ISSUES ASSOCIATED TO THE STERRAD 100NX FOUND THERE IS NOT A SIGNIFICANT TREND. THE FMEA (FAILURE MODE EFFECT ANALYSIS) RELATING TO HAZE / OIL MIST ISSUES WAS REVIEWED AND THE RISK WAS ACCEPTABLE. THE SHUMA (SYSTEM HAZARD USE AND MISUSE ANALYSIS) WAS REVIEWED. THE ADJUSTED RISK WAS CONSIDERED "BROADLY ACCEPTABLE". THERE WERE NO PARTS RETURNED FOR INVESTIGATION. BASED ON THE RISK AND THAT THERE IS NO SIGNIFICANT TREND, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AN ASP FSE WAS DISPATCHED TO THE CUSTOMER SITE REGARDING A REPORT OF OIL MIST. THE FSE ARRIVED ONSITE AND CONFIRMED THAT THE SEALS WERE OKAY. THE FSE REPLACED THE OIL MIST FILTER AND THE OIL RETURN VALVE AS A SAFETY PRECAUTION. THE FSE STATED HE PULLED VACUUM AND CHECKED FOR OIL MIST AND ALL WAS OKAY. TWO TEST CYCLES WERE RUN CHECKING FOR OIL MIST, THE SYSTEM WAS REPORTED TO BE WORKING NORMALLY. THE FILTER THAT WAS REPLACED ((B)(4)) WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER REPORTED A FINE MIST COMING FROM THEIR STERRAD 100NX 1-DR SYSTEM ((B)(4)). THERE ARE NO REPORTS OF HARM OR INJURY TO ANY HEALTHCARE WORKER. AN ASP FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT ONSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 1042090108

    Patients

    Seq Age Sex Outcome Treatment
    1