BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZER

    MDR report key: 4182527 · Received October 17, 2014

    Report

    Report Number
    2084725-2014-00333
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: 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 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 (04/10/2014 TO 10/07/2014) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. (B)(4). THE FMEA REVEALED THE RISK PRIORITY NUMBER FOR THIS FAILURE MODE IS GREATER THAN THE ACCEPTABLE LIMIT. A CAPA WAS OPENED TO ADDRESS THIS ISSUE. ¿THE HHE 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 DETERMINED THE RISK IS AS LOW AS REASONABLY PRACTICABLE FOR EXPOSURE TO ODOR OR ODORANTS. THE CAPA IDENTIFIED THE ROOT CAUSE FOR THE ODOR/SMELLS ISSUE AS: 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. THE USE OF A LESS OXIDATIVELY STABLE VACUUM PUMP OIL CAUSED THE ODOR/SMELLS FOR THE STERRAD® 200 SYSTEM. THE CATALYTIC CONVERTER WAS RETURNED AND TESTED. THE CATALYTIC CONVERTER EXHIBITED AN ODOR. THE REASON FOR RETURN OF THE CATALYTIC CONVERTER WAS CONFIRMED. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER PERFORMED A PREVENTATIVE MAINTENANCE (PM1) AND THE CATALYTIC DECOMP FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2014.

    Description of Event or Problem · 1

    WHILE ONSITE SERVICING THE STERRAD® 200 STERILIZER FOR A SCHEDULED PREVENTATIVE MAINTENANCE, 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 3(B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661072 STERRAD 200 STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1