BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMALL STEAM STERILIZER 16" CENTURY VAC

    MDR report key: 1029634 · Received April 14, 2008

    Report

    Report Number
    2515984-2008-00006
    Event Type
    Other
    Date Received
    April 14, 2008
    Date of Event
    March 13, 2008
    Report Date
    April 14, 2008
    Manufacturer
    STERIS CORPORATION - ERIE
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN ORDERED AND REPLACED STEAM MANIFOLD KITS TO ENSURE COMPONENTS WERE IN PROPER OPERATING CONDITION. UPON REBUILT OF STEAM MANIFOLD IT WAS FOUND THAT THERE WAS A BUILD UP OF SOME SORT OF MINERAL IN THE S2 VALVE. TECHNICIAN SPOKE WITH THE OPERATORS. THE EMPLOYEE WILL SET UP A TIME FOR AN IN-SERVICE ON PROPER PPE AND STERILIZER SAFETY. LOOKS LIKE AN ERROR OF THE OPERATOR AND AN OPPORTUNITIES IN THE UTILITY (STEAM) OF THE CUSTOMER. THE STERIS TECHNICIAN MENTIONED THAT THIS CUSTOMER IS AWARE OF FACILITY ISSUES CAUSED BY THEIR WATER SUPPLY. CUSTOMER HAD BEEN BILLED SEVERAL TIMES DUE TO ISSUES BY SEDIMENT BUILD UP.

    Description of Event or Problem · 1

    AFTER THE AUTOCLAVE COMPLETED ITS CYCLE THE EMPLOYEE REACHED INTO THE AUTOCLAVE TO REMOVE ITEMS AND WAS BURNED BY STEAM. OPERATOR BURNED WHEN REMOVING DART TEST FROM THE UNIT WITHOUT WEAR PROPER PPE AND VERIFY THAT THE CHAMBER WAS CLEAR OF STEAM AFTER OPENING THE DOOR. THE OPERATOR MANUAL P129367-547 MAKES MENTIONED OF A LISTING OF SAFETY PRECAUTIONS THAT MUST BE OBSERVED WHEN OPERATING OR SERVICING THE UNIT. THE WARNING LABEL WAS PRESENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMALL STEAM STERILIZER 16" CENTURY VAC STERILIZER FLE STERIS CORPORATION - ERIE 1021100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention