BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2071178 · Received April 27, 2011

    Report

    Report Number
    2084725-2011-00028
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 THE SYSTEM HAZARD USE 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 IS CONSIDERED LOW. THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) WAS CONSIDERED "AS LOW AS REASONABLY PRACTICABLE" (ALARP). BASED ON THE INVESTIGATION FINDINGS, THE ISSUE FOR HAZE/OIL MIST WAS RESOLVED WHEN THE FSE RE-INSTALLED THE OIL MIST FILTER CARTRIDGE, TIGHTENED THE MOUNTING SCREW, AND REPLACED OF THE CATALYTIC CONVERTER FILTER. BASED ON THE RISK AND THAT THERE IS NO SIGNIFICANT TREND, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AN ASP FIELD SERVICE ENGINEER FOUND THAT THE OIL MIST FILTER CARTRIDGE MOUNTING SCREW HAD COME OFF. THE FSE REINSTALLED THE OIL MIST FILTER CARTRIDGE AND TIGHTENED THE MOUNTING SCREW. THE CATALYTIC CONVERTER WAS ALSO REPLACED. THE FSE RAN A VACUUM TEST AND CHECKED FOR ANY EMISSION FROM THE CONVERTER. THE FSE ALSO RAN AN EMPTY CHAMBER FLEX CYCLE TO TEST. THE SYSTEM PERFORMS TO SPECIFICATIONS. A REPLACED PART IS EXPECTED TO BE RETURNED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS OF THE RETURN SAMPLE.

    Description of Event or Problem · 1

    A FACILITY BIOMED REPORTED A HAZE IN THE MECHANICAL ROOM WHERE STERRAD 100NX STERILIZER IS INSTALLED. THERE IS NO REPORT OF HARM OR INJURY TO ANY HEALTHCARE WORKER. AN ASP FSE WAS DISPATCHED ONSITE TO ASSESS THE UNIT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1