BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD 100S STERILIZER

    MDR report key: 1633740 · Received March 17, 2010

    Report

    Report Number
    2084725-2010-00081
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 18, 2010
    Report Date
    February 18, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MLR
    PMA / PMN Number
    K991999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION RESULTS: THE STERRAD 100S WAS SERVICED AND THE FSE FOUND NO ISSUE WITH THE UNIT. THE POWER VOLTAGE WAS CHECKED. THE VACUUM, INJECTION, PLASMA, AND LEAK TESTS WERE PERFORMED AND NO PROBLEM WAS FOUND. THE FSE ALSO INSPECTED THE INSIDE OF THE CHAMBER AND FOUND NO ABNORMALITIES. THE COMPLAINT TREND FOR H2O2 CONTACT ISSUES ON THE STERRAD 100S WAS REVIEWED. THE OVERALL TREND HAS BEEN BELOW THE UPPER CONTROL LIMIT (UCL). THE DEFECTS PER MILLION OPPORTUNITY (DPMO) ANALYSIS IS WITHIN THE CONTROL LIMIT AND IS CONSIDERED TO BE A LOW RISK TREND. THE COMPLAINT TREND FOR WHITE RESIDUE ISSUE ON THE STERRAD 100S WAS REVIEWED. THE OVERALL TREND HAS BEEN BELOW THE UPPER CONTROL LIMIT (UCL). THE DPMO ANALYSIS IS WITHIN THE CONTROL LIMIT AND THE TREND IS CONSIDERED TO BE LOW RISK. THERE IS NO TREND OF H2O2 SKIN CONTACT OR WHITE RESIDUE ISSUE, BASED ON THE SERVICE AND COMPLAINT HISTORY OF THIS MACHINE FROM THE LAST SIX MONTHS ((B)(4) 2009 THROUGH (B)(4) 2010). THE HEALTH HAZARD EVALUATION HHE WAS REVIEWED FOR SKIN CONTACT, H2O2 ISSUE. THE HHE HEALTH INDEX IS CONSIDERED LIMITED (TRANSIENT, SELF-LIMITING ILLNESS OR MINOR INJURY). THE SYSTEM HAZARD AND USER MISUSE ANALYSIS (SHUMA) SHOWS THAT THE RISK INDEX ASSOCIATED WITH EXPOSURE TO H2O2 RESIDUE ON LOAD SURFACE IS CATEGORY I OR "BROADLY ACCEPTABLE RISK". THE HEALTH HAZARD EVALUATION (HHE) WAS REVIEWED FOR THE WHITE POWDER RESIDUE ISSUE. THE HHE HEALTH INDEX IS NONE/ NEGLIGIBLE. THE SEVERITY OF THE INJURY IS CONSIDERED LIMITED (TRANSIENT, SELF-LIMITING ILLNESS OR MINOR INJURY). A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS STERRAD 100S SYSTEM ((B)(4)) RELEASED ON 7/15/05 SHOWS THAT THE SYSTEM MET ALL SPECIFICATIONS AT THE TIME OF RELEASE FOR SHIPMENT, AND THERE WERE NO ISSUES RELATED TO THESE FAILURE MODES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HEALTHCARE WORKER (HCW) EXPERIENCED A BURN WHEN TOUCHING A WHITE SUBSTANCE THAT WAS ON THE LOAD FROM A COMPLETED STERRAD 100S CYCLE. THE SYMPTOM REPORTED WAS A BURN ON THE FINGERS OF BOTH HANDS. THE HCW WASHED THE AREA WITH RUNNING WATER. ADDITIONAL INFORMATION IS PENDING A SITE VISIT AND WILL BE REPORTED UPON RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD 100S STERILIZER STERRAD EQUIPMENT (MLR) MLR ADVANCED STERILIZATION PRODUCTS NA 059399

    Patients

    Seq Age Sex Outcome Treatment
    1