BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 200 STERILIZER

    MDR report key: 3112683 · Received May 14, 2013

    Report

    Report Number
    2084725-2013-00202
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 16, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K030429
    Removal / Correction Number
    Z-1026-1027-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 (PM2) WAS PERFORMED AND THE CATALYTIC DECOMP FILTER WAS REPLACED. UNIT MEETS SPECIFICATIONS AND WAS RETURNED TO SERVICE ON (B)(6) 2013.

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: OTHER: 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 TRENDING FOR PROBLEM CODE ALLERGIC REACTION (JANUARY 2013 ¿ DECEMBER 2013) REVEALED THE RISK IS CONSIDERED AS LOW AS REASONABLY PRACTICABLE. 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. THE CATALYTIC CONVERTER WAS RETURNED AND TESTED. THE CATALYTIC CONVERTER EXHIBITED NO ODOR. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE.

    Description of Event or Problem · 1

    INITIAL MEDWATCH REPORT 2084725-2013-00202. A CUSTOMER REPORTED AN EVENT OF A "GAS ODOR/SMELL" EMITTING FROM THE STERRAD 200 STERILIZER. A TOTAL OF FIVE HEALTHCARE WORKERS EXPERIENCED HUMAN REACTIONS DUE TO THE ODOR. FOUR HCWS "EXPERIENCED SKIN RASH AND IRRITATION ON ARMS, NECK, AND HANDS." THESE FOUR HCWS DID NOT SEEK MEDICAL ATTENTION/TREATMENT AND ARE REPORTED TO BE "OKAY." ONE HCW IS REPORTED TO HAVE "EXPERIENCED REALLY BAD SHINY COLORED HIVES ON ARMS AND NECK." THE HCW WAS GIVEN TOPICAL BENADRYL CREAM AND WAS SENT TO SEEK MEDICAL ATTENTION FROM A DOCTOR OUTSIDE OF THEIR FACILITY. THE HCW'S PERSONAL DOCTOR GAVE HER ADDITIONAL BENADRYL CREAM TO TREAT THE HIVES. PER THE HCW, THE SYMPTOMS LASTED ONE WEEK AND SHE NOW REPORTS TO BE "DOING GREAT." A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE UNIT ONSITE. THIS COMPLAINT IS BEING REPORTED TO FDA AS A SERIOUS INJURY REPORT FOR SYMPTOMS RELATED TO THE ODOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213027 STERRAD 200 STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1