BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1647423 · Received March 31, 2010

    Report

    Report Number
    2084725-2010-00099
    Event Type
    Malfunction
    Date Received
    March 31, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 10, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    NO ONSITE SERVICE WAS PERFORMED SINCE THE STERILIZER DID NOT HAVE ANY ISSUE AND THE CYCLE WAS COMPLETED WITHOUT ANY PROBLEM PRIOR TO THE INCIDENT. ASP INVESTIGATION SUMMARY: THERE WAS NOT A MALFUNCTION OF THE ASP STERRAD SYSTEM. THE HEALTHCARE WORKER EXPERIENCED HYDROGEN PEROXIDE CONTACT AS A RESULT OF A FAILURE TO FOLLOW INSTRUCTIONS. THE USERS' MANUAL OF THE STERRAD 100S (99008-02) ON PAGE 47 UNDER "REMOVING THE VAPORIZER PLATE" WARNS THE CUSTOMER: "WARNING! YOU MUST WEAR EYE PROTECTION AND CHEMICAL RESISTANT LATEX, PVC(VINYL) OR NITRIL GLOVES WHILE PERFORMING THIS PROCEDURE." THE COMPLAINT TREND FOR H2O2 CONTACT ISSUES ON THE STERRAD 100S FROM (B)(4) 2009 THROUGH (B)(4) 2010 INDICATES THERE IS NO SIGNIFICANT TREND. THE DEFECTS PER MILLION OPPORTUNITY (DPMO) TREND IS CONSIDERED TO BE LOW RISK. THE HEALTH HAZARD EVALUATION (HHE) WAS REVIEWED. THE SEVERITY OF THE INJURY IS CONSIDERED LIMITED (TRANSIENT, SELF-LIMITING ILLNESS OR MINOR INJURY). THE SYSTEM HAZARD AND USER MISUSE ANALYSIS (SHUMA) INDICATES THAT THE EXPOSURE TO H2O2 RESIDUALS IS CATEGORY1 OR "BROADLY ACCEPTABLE RISK". THE STERRAD 100S SYSTEM ((B)(4)) DEVICE HISTORY RECORD (DHR) WAS REVIEWED, THERE WERE NO ISSUES RELATED TO THIS COMPLAINT.

    Description of Event or Problem · 1

    A HEALTHCARE WORKER (HCW) EXPERIENCED HYDROGEN PEROXIDE CONTACT ON THE INDEX AND MIDDLE FINGER OF THE RIGHT HAND. THE HCW RINSED THE AREA FOR 15 MINUTES AFTER EXPOSURE AND THE SYMPTOMS RESOLVED. THE CONTACT HAPPENED WHILE THE HEALTHCARE WORKER WAS CLEANING OUT THE VAPORIZER PLATE AND WAS NOT WEARING PPE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1