BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2943873 · Received February 5, 2013

    Report

    Report Number
    2084725-2013-00050
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K071385
    Removal / Correction Number
    Z-1026-1027-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: OCTOBER 10, 2008. CONCLUSION: ROOT CAUSE IDENTIFIED IN CAPA WAS FOUND TO BE PREMATURE FAILURE/SATURATED OIL MIST FILTER OR VACUUM PUMP OIL. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, SERVICE HISTORY, TRENDING OF THE PRODUCT MALFUNCTION CODE, FAILURE MODE AND EFFECTS ANALYSIS, HEALTH HAZARD EVALUATION, SYSTEM HAZARD AND USER MISUSE ANALYSIS, AND CAPA. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND NO ISSUES REGARDING THE FAILURE MODE WERE NOTED. THE INVOLVED UNIT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE HISTORY FOR THIS UNIT FOR THE PAST 6 MONTHS (07/22/2012 TO 01/18/2013), DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. THE TREND OF THE PRODUCT MALFUNCTION CODE HUMAN REACTION WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND REVEALED AN OVERALL RISK OF 'BROADLY ACCEPTABLE". THE TREND OF THE PRODUCT MALFUNCTION CODE FLUID LEAK WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND REVEALED AN OVERALL RISK OF 'BROADLY ACCEPTABLE". THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER SCORES ARE BELOW 100 AND ARE CONSIDERED ACCEPTABLE. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE RISK OF ODOR AND SMELL EXPOSURE. THE SEVERITY AND OCCURRENCE FOR THE GENERAL POPULATION WERE LIMITED (TRANSIENT, MINOR IMPAIRMENT, NO MEDICAL TREATMENT REQUIRED) AND THE PRODUCT PROBLEM HAS BEEN KNOWN TO RESULT IN THE IDENTIFIED HARM DOCUMENTED OR REPORTED IN CLINICAL PRACTICE, BUT ONLY OCCASIONALLY AND/OR UNDER UNUSUAL CIRCUMSTANCES. THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) SHOWS THAT THE RISK IS AS LOW AS REASONABLY PRACTICAL FOR EXPOSURE TO ODOR OR ODORANTS. THE CAPA (CORRECTIVE AND PREVENTATIVE ACTION) IDENTIFIED THE ROOT CAUSE FOR THE ODOR/SMELLS ISSUE AS: (1) PREMATURE FAILURE OF THE USED AND SATURATED STERRAD® 100NX OIL MIST FILTER CAUSED OIL VAPOR EMISSIONS THAT EXACERBATED THE ODOR/SMELL COMPLAINTS REPORTED FOR THE STERRAD® 100NX SYSTEM. (2) THE USE OF A LESS OXIDATIVELY STABLE VACUUM PUMP OIL CAUSED THE ODOR/SMELLS FOR THE STERRAD® 100NX SYSTEM. THE RETURNED CATALYTIC CONVERTER AND THE OIL MIST FILTER WERE UNABLE TO PASS FUNCTIONAL TESTING AND THE CAUSE WAS CONFIRMED. THE OIL MIST FILTER WAS INSTALLED ON THE STERRAD® 100NX TEST STANDARD. VERY LIGHT WISPS OF MIST WAS OBSERVED. THE OIL MIST FILTER WAS REMOVED AND THE CATALYTIC DECOMP. FILTER WAS INSTALLED. THE STERRAD® 100NX SYSTEM HAD A STRONG ODOR WITH THE INSTALLED CATALYTIC DECOMP. FILTER. THE REASON FOR RETURN WAS CONFIRMED. THE ISSUE HAS BEEN 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 AN ODOR AND OIL LEAKING FROM THE BACK/BOTTOM OF THE STERRAD 100NX. HEALTHCARE WORKER 2 (HCW2) REPORTED A REACTION OF NAUSEA LASTING TEN MINTUES. HCW2 DID NOT RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND IS NOW "OK." THE CUSTOMER STATED THERE IS ALSO A SCOPE WASHER IN THE ROOM WITH CIDEX OPA AND PERECIDIC ACID WHICH ARE ENCLOSED OR SEALED. 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 FROM AN ODOR DATED 11/30/2012. 1-H4B8KN AND 1-H4BLMW ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS TWO OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2013-00049 AND 2084725-2013-00050.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49189 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1