BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200, SINGLE DOOR

    MDR report key: 2863654 · Received December 10, 2012

    Report

    Report Number
    2084725-2012-00096
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1026-1027-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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 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 FOR THIS FAILURE MODE IS 128 WHICH IS GREATER THAN THE ACCEPTABLE LIMIT. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. 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) DETERMINED THE RISK IS AS LOW AS REASONABLY PRACTICABLE 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® 200 OIL MIST FILTER CAUSED OIL VAPOR EMISSIONS THAT EXACERBATED THE ODOR/SMELL COMPLAINTS REPORTED FOR THE STERRAD® 200 SYSTEM. (2) THE USE OF A LESS OXIDATIVELY STABLE VACUUM PUMP OIL CAUSED THE ODOR/SMELLS FOR THE STERRAD® 200 SYSTEM.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A DEVICE HISTORY REVIEW, A REVIEW OF THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND THE SYSTEM SERIAL NUMBER, HEALTH HAZARD EVALUATION, FAILURE MODE AND EFFECTS ANALYSIS, CORRECTIVE ACTION AND PREVENTIVE ACTION AND SUPPLIER CORRECTIVE ACTION REPORT. DHR (DEVICE HISTORY REVIEW) FOR STERRAD 200 SYSTEM CONFIRMED THAT THE PRODUCT MET ALL SPECIFICATIONS AT THE TIME OF RELEASE. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD 200 HAS NOT OBSERVED ANY SIGNIFICANT TREND FOR THIS ISSUE. TRENDING ANALYSIS FOR "ODOR/SMELL" ISSUES ASSOCIATED TO THE STERRAD 200 FOUND THE TREND BREACHES THE UPPER CONTROL LIMIT AND IS ADDRESSED IN THE INVESTIGATION CONTAINED WITHIN CAPA. HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR ODOR ISSUES. PER THE HHE, "THE PRODUCT PROBLEM HAS BEEN KNOWN TO RESULT IN THE IDENTIFIED HARM, BUT ONLY OCCASIONALLY AND/OR UNDER UNUSUAL CIRCUMSTANCES. THE RISK OF INJURY DUE TO MILD EXPOSURE TO SMELLS AND ODORS IS LOW". FMEA (FAILURE MODE EFFECTS ANALYSIS) WAS REVIEWED. THE RPN FOR THIS FAILURE MODE IS GREATER THAN THE ACCEPTABLE LIMIT. CAPA (CORRECTIVE ACTION AND PREVENTIVE ACTION) ADDRESSES AND MITIGATES THE ASSOCIATED RISKS OF ODOR/SMELLS ON THE STERRAD 200 SYSTEM. SCAR (SUPPLIER CORRECTIVE ACTION REPORT) WAS ISSUED TO THE OIL MIST FILTER MANUFACTURER, (B)(4) MANUFACTURE, INC., TO INVESTIGATE THIS ROOT CAUSE. UPON ARRIVAL AT THE CUSTOMER SITE, THE FSE CONFIRMED THE REPORTED ODOR, AND REPLACED THE CATALYTIC CONVERTER, VACUUM PUMP OIL AND OIL MIST FILTER. THE OIL MIST FILTER AND CATALYTIC CONVERTER WERE RETURNED AND TESTED. THE OIL MIST FILTER FAILED TESTING AS IT EXHIBITED A SMALL AMOUNT OF OIL MIST FROM THE TOP CAP. THE REASON FOR RETURN OF THE OIL MIST FILTER WAS CONFIRMED. THE CATALYTIC CONVERTER FAILED TESTING AS IT HAD A VERY LIGHT ODOR. THE REASON FOR RETURN OF THE CATALYTIC CONVERTER WAS CONFIRMED. THE ISSUE WAS RESOLVED BY REPLACING THE OIL MIST FILTER AND CATALYTIC CONVERTER. CAPA INVESTIGATION IDENTIFIED THE TWO ROOT CAUSES FOR THE ISSUE OF ODOR EMISSION THAT RESULTED IN REPORTED COMPLAINTS WITH PMC "ODOR/SMELLS" FOR THE STERRAD 200 SYSTEM. ONE ROOT CAUSE WAS THE PREMATURE FAILURE OF THE STERRAD 200 OIL MIST FILTER, WHICH CAUSED EMISSION OF VACUUM EXHAUST OIL MIST. THE SECOND ROOT CAUSE WAS INHERENT ODOR ASSOCIATED WITH THE STERRAD 200 VACUUM PUMP MINERAL OIL (LUBRICANT).

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PM2 WAS PERFORMED AND THE CATALYTIC DECOMP FILTER WAS REPLACED.

    Additional Manufacturer Narrative · 1

    IF REMEDIAL ACTION INITIATED, CHECK TYPE: CORRECTED REMEDIAL ACTION TYPE FROM RECALL TO NOTIFICATION LIST CORRECTION/REMOVAL REPORTING NUMBER: CORRECTED REPORTING NUMBER FROM (B)(4) TO (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF ODOR EMITTING FROM THE STERRAD 200. THERE WAS NO REPORT OF HUMAN REACTION. THE UNIT WAS TAKEN OUT OF SERVICE AND 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
    1 STERRAD 200, SINGLE DOOR STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1