BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2911688 · Received January 11, 2013

    Report

    Report Number
    2084725-2013-00026
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. THE VACUUM PUMP, CATALYTIC DECOMP FILTER, CARTRIDGE AND FILTER WERE REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN. MANUFACTURER DATE: JUNE 26, 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 (07/07/2012 TO 01/03/2013) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM MARCH 2012 THROUGH FEBRUARY 2013 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. 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 SOLBERG FILTER AND CATALYTIC FILTER WERE RETURNED FOR INVESTIGATION. VISUAL ANALYSIS FOUND NO DAMAGE ON THE SOLBERG FILTER OR THE CATALYTIC FILTER. SYSTEM FUNCTIONAL TESTING- INSTALLED CATALYTIC FILTER ON THE STERRAD® 100NX TEST UNIT. PERFORMED PUMP DOWN AND VERIFIED A SLIGHT ODOR EMITTING FROM THE CATALYTIC FILTER. THE REASON FOR RETURN IS CONFIRMED. SYSTEM FUNCTIONAL TESTING- INSTALLED SOLBERG FILTER ON THE STERRAD® 100NX TEST UNIT. PERFORMED PUMP DOWN AND VERIFIED THAT OIL MIST WAS EMITTING FROM THE SOLBERG FILTER. THE REASON FOR RETURN IS 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 ODOR EMITTING FROM THE STERRAD 100NX. THERE WAS NO REPORT OF HUMAN REACTION. 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 DATED (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16659 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1