BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD NX STERILIZER

    MDR report key: 1691725 · Received May 17, 2010

    Report

    Report Number
    2084725-2010-00173
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 27, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K042116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF DEVICE HISTORY RECORD REVIEW, THE SERVICE AND COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, HEALTH HAZARD EVALUATION AND THE SYSTEM HAZARD AND USER MISUSE ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR STERRAD NX STERILIZER (SN: (B)(4)) RELEASED ON (B)(4) 2008 SHOWS THAT THE SYSTEM MET ALL SPECIFICATIONS AT THE TIME OF RELEASE FOR SHIPMENT, AND THERE WERE NO ISSUES RELATED TO THESE FAILURE MODES. THE SERVICE AND COMPLAINT HISTORY FOR THE STERRAD NX STERILIZER (SN: (B)(4)) WAS REVIEWED FOR THE LAST (B)(4) FROM THE ALERT DATE. THERE IS NOT A TREND OF THIS ISSUE. TRENDING ANALYSIS FOR H2O2 SKIN CONTACT ISSUES ASSOCIATED TO THE STERRAD NX DID NOT INDICATE A SIGNIFICANT TREND. SKIN CONTACT- H2O2 ISSUES ON THE STERRAD NX PRODUCT LINE ((B)(4) 2009 THRU (B)(4) 2010) WAS REVIEWED. THE OVERALL TREND HAS BEEN BELOW THE UPPER CONTROL LIMIT (UCL). SINCE THE UCL CHANGES EVERY MONTH, THE DPMO THAT HITS THE UCL DURING (B)(4) 2010 IS INSIGNIFICANT. THE DPMO ANALYSIS FOR THE MOST RECENT MONTH ((B)(4) 2010) WITH THE UNCHANGED UCL SHOWS THAT THE TREND IS WELL WITHIN THE CONTROL LIMIT. THEREFORE, THE TREND IS CONSIDERED TO BE LOW RISK TREND. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR THE SKIN CONTACT, H2O2 ISSUE. THE HHE HEALTH INDEX IS (B)(4) OR NONE/ NEGLIGIBLE. THE SEVERITY OF THE INJURY IS CONSIDERED LIMITED (TRANSIENT, SELF-LIMITING ILLNESS OR MINOR INJURY) THE SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) SHOWS THAT THE RISK INDEX IS (B)(4), WHICH IS (B)(4) OR "BROADLY ACCEPTABLE RISK". THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE UNIT. THE FSE PERFORMED INSPECTION AND VERIFICATION OF ALL MEASURES: VOLTAGE, PRESSURES, TEMPERATURES AND RF. NO ABNORMALITIES WERE FOUND WITH THE STERILIZER. NO PARTS WERE RETURNED FOR THIS COMPLAINT. THE USER'S MANUAL FOR THE STERRAD NX ((B)(4)) ON PAGE 12 STATES: "IF WHITE RESIDUE IS VISIBLE ON THE LOAD; THIS MAY BE RESIDUE FROM THE HYDROGEN PEROXIDE STABILIZER. WEAR CHEMICAL RESISTANT LATEX, PV (VINYL), OR NITRILE GLOVES WHEN REMOVING A LOAD WITH VISIBLE WHITE RESIDUE". THUS THIS ISSUE CAN BE ATTRIBUTED TO THE USER NOT CORRECTLY FOLLOWING THE USER GUIDE'S INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    THE IFU STATES THE FOLLOWING: WARNING! HYDROGEN PEROXIDE IS CORROSIVE CONCENTRATED HYDROGEN PEROXIDE IS CORROSIVE TO SKIN, EYES, NOSE, THROAT, LUNGS, AND THE GASTROINTESTINAL TRACT. ALWAYS WEAR CHEMICAL RESISTANT LATEX, PVC (VINYL), OR NITRILE GLOVES WHEN REMOVING ITEMS FROM THE STERILIZER FOLLOWING A CANCELLED CYCLE OR IF ANY MOISTURE IS NOTED ON ITEMS IN THE LOAD FOLLOWING A COMPLETED CYCLE. PER THE IFU, ALL ITEMS MUST BE CLEANED AND THOROUGHLY DRIED BEFORE LOADING INTO THE STERILIZER. LOADS CONTAINING MOISTURE MAY CAUSE CYCLE CANCELLATION.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER CALLED TO REPORT THAT A HEALTHCARE WORKER (HCW) HAD H2O2 CONTACT WHILE REMOVING THE LOAD FROM THE STERRAD NX AFTER A COMPLETED CYCLE. AFTER REMOVING THE LOAD FROM THE STERILIZER, HE FELT AN ITCH AND HAD A WHITE SKIN REACTION WITH A H2O2 ODOR. HE WASHED THE HANDS WITH ABUNDANT WATER. THE NEXT DAY, HE NOTICED A BURN LIKE A RED SPOT ON THE SKIN OF 0.5 INCHES. THE SYMPTOMS RESOLVED IN TWO DAYS. THE HCW WAS NOT WEARING PPE. NO MEDICAL INTERVENTION WAS SOUGHT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR H2O2