BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 3200132 · Received July 1, 2013

    Report

    Report Number
    2084725-2013-00289
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE VACUUM PUMP OIL, CATALYTIC DECOMP FILTER AND THE OIL MIST FILTER. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    SEX IS UNKNOWN. MANUFACTURER DATE: NOVEMBER 29, 2012. 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 (12/16/2012 TO 06/14/2013) 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 CASSETTE NOT ACCEPTED WAS COMPLETED FROM JANUARY 2013 THROUGH DECEMBER 2013 AND DID NOT REVEAL A SIGNIFICANT TREND OVER THE PAST 12 MONTHS. ¿ THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER SCORES ARE BELOW 100 AND ARE CONSIDERED ACCEPTABLE. ¿ THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER SCORES FOR ALL CASSETTE NOT ACCEPTED FAILURE MODES 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 FSE WENT ONSITE AND CONFIRMED CASSETTE NOT ACCEPTED AND ODOR/SMELLS. HE ADJUSTED THE DELIVERY SYSTEM SPRINGS TO RESOLVE THE CASSETTE NOT ACCEPTED ISSUE. THE FSE ALSO REPLACED THE OIL, SOLBERG CARTRIDGE FILTER AND THE CATALYTIC DECOMP FILTER TO RESOLVE THE REPORTED ODOR ISSUE. THE MACHINE WAS RESTORED. -TRACKING AND TRENDING DATA FOR THE DELIVERY SYSTEM SPRINGS ADJUSTMENT DID NOT IDENTIFY A TREND THAT NEEDED FURTHER INVESTIGATION. AS A RESULT, ROOT OR ASSIGNABLE CAUSE ANALYSIS WAS NOT PERFORMED. -THE OIL MISTER FILTER CARTRIDGE WAS RETURNED AND INSTALLED ONTO A QA CERTIFIED TEST SYSTEM. DURING TESTING, IT WAS ABLE TO PASS FUNCTIONAL TESTING AND NO MIST OR ODOR WAS DETECTED. THE REASON FOR RETURN WAS NOT CONFIRMED. -THE CATALYTIC CONVERTER WAS RETURNED. DURING FUNCTIONAL TESTING, THERE WAS NO ODOR DETECTED FROM THE CATALYTIC CONVERTER. IT WAS FOUND TO BE SATURATED WITH OIL. THE REASON FOR RETURN WAS CONFIRMED. -THE PUMP OIL WAS RETURNED. IT WAS VISUALLY VERIFIED THAT THE OIL WAS DISCOLORED. 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

    WHILE ONSITE SERVICING THE STERRAD 100NX STERILIZER FOR ANOTHER ISSUE, AN ASP FIELD SERVICE ENGINEER (FSE) DISCOVERED AN ODOR EMITTING FROM THE UNIT. THERE WAS NO REPORT OF HUMAN REACTION. THIS EVENT IS BEING REPORTED AS A MALFUNCTION REPORT SUBSEQUENT TO A SERIOUS INJURY EVENT DATED (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299328 STERRAD 100NX STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1