BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1515987 · Received October 19, 2009

    Report

    Report Number
    2084725-2009-00592
    Event Type
    Injury
    Date Received
    October 19, 2009
    Date of Event
    September 22, 2009
    Report Date
    September 22, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THIS EVENT WAS REPORTED TO ASP, A FIELD SERVICE ENGINEER (FSE) CONTACTED THE ACCOUNT. PER THE FSE, THE VAPORIZER PLATE WAS MISSING FROM THE UNIT. HE INSTRUCTED THE INITIAL REPORTER TO REPLACE THE VAPORIZER PLATE. THE UNIT MEETS MANUFACTURER REQUIRED SPECIFICATIONS. AN ASP FSE CONTACTED THE INITIAL REPORTER. PROVIDED INSTRUCTIONS TO REPLACE THE VAPORIZER PLATE ON THE UNIT. THE FREQUENCY OF EXPOSURE TO THE STERRAD STERILIZER WAS REPORTED AS INTERMITTENTLY THROUGHOUT THE WORKDAY. AT THE TIME OF THIS INCIDENT, THE STERRAD STERILIZATION CYCLE HAD COMPLETED. PER THE FSE, THE VAPORIZER PLATE WAS NOT IN PLACE. THE LOAD CONSISTED OF (1) POWERPRO BATTERY WRAPPED IN KIMBERLY CLARK STERILIZATION WRAP (BLUE WRAP). OTHER LOAD RELATED INFORMATION WAS NOT PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER WAS PROVIDED WITH THE H2O2 MATERIAL SAFETY DATA SHEET. PER THE STERRAD 100S USER'S GUIDE: VERIFY THAT THE VAPORIZER PLATE IS IN PLACE PRIOR TO STARTING A CYCLE. A VAPORIZER PLATE IS INSTALLED IN ALL STERRAD 100S STERILIZERS. THIS VAPORIZER PLATE MINIMIZES THE RISK OF LIQUID HYDROGEN PEROXIDE COMING INTO CONTACT WITH THE LOAD IN THE CHAMBER. IT ALSO HELPS KEEP THE LOAD AND THE CHAMBER CLEAN. OPERATION OF THE STERRAD 100S STERILIZER WITHOUT THE VAPORIZER PLATE IN PLACE MAY RESULT IN HYDROGEN PEROXIDE REMAINING ON THE LOAD AFTER A SUCCESSFULLY COMPLETED CYCLE. RESIDUAL HYDROGEN PEROXIDE REMAINING ON THE LOAD CAN RESULT IN OPERATOR CONTACT AND/OR INJURY. THE VAPORIZER PLATE IS ALSO CHANGED EVERY TIME YOU PUT IN A NEW CASSETTE COLLECTION BOX. REPLACE THE VAPORIZER PLATE EVERY 30 DAYS OR 145 CYCLES, WHICHEVER OCCURS FIRST.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM THE FIELD INDICATING A HEALTHCARE WORKER SUSTAINED H2O2 BURNS WHEN REMOVING A LOAD FROM A COMPLETED CYCLE FROM THE STERRAD UNIT. THE WORKER WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE). THE H2O2 CONTACT WAS ON THE INDEX FINGER AND THUMB OF LEFT HAND. THERE WAS BURNING SENSATION AND SKIN TURNED WHITE. THE WORKER PERFORMED FIRST AID MEASURE OF SOAPING AND RINSING FOR 15 MINUTES, AND WAS THEN SENT TO THE EMPLOYEE'S HEALTH OFFICE BY THE EMPLOYER. DURATION OF SYMPTOMS WAS 20 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention