BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 200 STERILIZER

    MDR report key: 3963746 · Received July 29, 2014

    Report

    Report Number
    2084725-2014-00142
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FLF
    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

    A FIELD SERVICE ENGINEER WAS DISPATCHED TO CUSTOMER SITE. ODOR/SMELL WAS CONFIRMED. A PREVENTATIVE MAINTENANCE (PM1) WAS PERFORMED AND THE CATALYTIC DECOMP FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(4) 2014.

    Additional Manufacturer Narrative · 1

    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 (10/06/2013 TO 04/04/2014) DID NOT REVEAL A SIGNIFICANT TREND FOR THIS SAME ISSUE. THE TREND OF THE PRODUCT MALFUNCTION CODE ODOR/SMELLS WAS COMPLETED FROM MAY 2013 THROUGH APRIL 2014 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. THE TRENDING FOR PROBLEM CODE HUMAN REACTION (MAY 2013 THROUGH APRIL 2014) REVEALED THE HIGHEST RISK IS CONSIDERED BROADLY ACCEPTABLE. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RISK PRIORITY NUMBER FOR THIS FAILURE MODE IS (B)(4) 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: 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. 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 "STRONG ODOR" EMITTING FROM THE STERRAD 200 STERILIZER. ONE HEALTHCARE WORKER (HCW) EXPERIENCED A REACTION OF HEADACHE. THE HCW DID NOT SEEK OR RECEIVE ANY MEDICAL ATTENTION/TREATMENT AND REPORTED THE "HEADACHE IS GONE." 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) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441412 STERRAD 200 STERILIZER STERRAD EQUIPMENT (MLR) FLF ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA