BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200, SINGLE DOOR

    MDR report key: 3081626 · Received April 29, 2013

    Report

    Report Number
    2084725-2013-00194
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CUSTOMER HAS QUALIFIED ONSITE ENGINEERS AND THEY REPLACED THE OIL MIST FILTER THEMSELVES. AN ASP FIELD SERVICE ENGINEER WAS ONSITE AND CONFIRMED THE FIX AND PROBLEM RESOLUTION. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Additional Manufacturer Narrative · 1

    SEX IS UNKNOWN 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 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 (OCTOBER 2012 TO APRIL 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 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. NO PARTS WERE RETURNED FOR FURTHER EVALUATION. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN EVENT OF A "CHEMICAL SMELL" (ODOR) EMITTING FROM THE STERRAD 200 GMP STERILIZER (SN (B)(4)). THERE WAS NO REPORT OF HUMAN REACTION. THE CUSTOMER WAS ADVISED TO DISCONTINUE USING THE UNIT. 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) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185560 STERRAD 200, SINGLE DOOR STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1