BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100NX STERILIZER

    MDR report key: 2871038 · Received December 12, 2012

    Report

    Report Number
    2084725-2012-00122
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: SEX IS UNKNOWN; RECALL TO NOTIFICATION: (B)(4); MANUFACTURER DATE: 02/19/2008. ROOT CAUSE IDENTIFIED IN CAPA WAS FOUND TO BE PREMATURE FAILURE/SATURATED OIL MIST FILTER OR VACUUM PUMP OIL CORRECTION: 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 RELATING TO 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 (06/01/2012 TO 11/28/2012) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. ¿ THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM 03/2012 THROUGH 02/2013 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, 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.

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATE: FEBRUARY 19, 2008. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY REVIEW, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND THE SYSTEM SERIAL NUMBER, HEALTH HAZARD EVALUATION, FAILURE MODE AND EFFECT ANALYSIS AND CORRECTIVE ACTION AND PREVENTIVE ACTION. 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 HAS NOT OBSERVED ANY SIGNIFICANT TREND FOR THIS SAME ISSUE. TRENDING ANALYSIS FOR "ODOR/SMELL" ISSUES ASSOCIATED TO THE STERRAD 100NX FOUND THE TREND TO GO ABOVE THE UPPER CONTROL LIMIT. TRENDING ANALYSIS FOR "HUMAN REACTION" ISSUES ASSOCIATED TO THE STERRAD 100NX FOUND THE RISK IS CONSIDERED TO BE "AS LOW AS REASONABLY PRACTICABLE" FOR THE MONTHS OF (B)(6) 2012 TO (B)(6) 2013. HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR ODOR ISSUES AND FINDS THE RISK OF INJURY DUE TO MILD EXPOSURE TO SMELLS AND ODORS IS LOW. CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) ADDRESSES AND MITIGATES THE ASSOCIATED RISKS OF ODOR/SMELLS ON THE STERRAD 100NX SYSTEM. THE ISSUE HAS BEEN RESOLVED AT THE CUSTOMER FACILITY. AFTER GOING ONSITE, THE FSE REPORTED NO PROBLEM FOUND. PARTS WERE NOT RETURNED FOR INVESTIGATION. THERE IS NO FURTHER INVESTIGATION. THE ISSUE WILL BE TRACKED AND TRENDED. THE ROOT CAUSE OF THE ODOR ISSUE IS BEING IDENTIFIED AS A PART OF CAPA. PER CAPA THE VACUUM PUMP MINERAL OIL CAN CAUSE THE ODOR.

    Description of Event or Problem · 1

    A FACILITY REPORTED AN ODOR EMITTING FROM THEIR STERRAD 100NX SYSTEM. A HEALTHCARE WORKER (HCW) REPORTED SYMPTOMS OF NAUSEA WHEN WORKING WITH OR NEAR THE STERRAD 100NX. THE HCW DID NOT SEEK MEDICAL ATTENTION OR RECEIVE ANY MEDICAL TREATMENT. 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. (B)(4). THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2012-00122 AND 2084725-2012-00123.

    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