BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERILIZER 16" CENTURY VAC

    MDR report key: 919939 · Received September 28, 2007

    Report

    Report Number
    2515984-2007-00001
    Event Type
    Injury
    Date Received
    September 28, 2007
    Date of Event
    September 4, 2007
    Report Date
    September 26, 2007
    Manufacturer
    STERIS CORPORATION-ERIE
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS SVC TECH INSPECTED THE CENTURY STEAM STERILIZER (16" PREVAC). THE TECH DISASSEMBLED AND INSPECTED THE S-2 VALVE AND FOUND IT TO BE IN GOOD CONDITION. THE TECHNICIAN TESTED THE STERILIZER OPERATION IN BOTH SERVICE MODE AND OPERATOR MODE WITH NO PROBLEMS. THE TECHNICIAN WAS UNABLE TO DUPLICATE THE STERILIZER MALFUNCTION AS DESCRIBED BY THE INJURED OPERATOR. THE CENTURY SMALL OPERATOR'S MANUAL (129367-408) IN THE SUMMARY OF WARNINGS AND CAUTIONS (PAGES 1-1 THROUGH 1-3), STERILIZATION TECHNIQUES - BIOLOGICAL MONITORS (PAGES 2-4) AND STERILIZER OPERATION (PAGES 4-1,PAGES 4-3 THROUGH 4-4) CLEARLY INFORM POTENTIAL USERS OF THE PROPER INSTRUCTIONS FOR PLACING A BIOLOGICAL INDICATOR IN THE STERILIZER AND THE NEED FOR PERSONAL PROTECTION EQUIPMENT WHEN PLACING ITEMS WITHIN THE STERILIZER. STERIS COMPLAINT HISTORY OVER A FIVE YEAR PERIOD INDICATES NO OTHER CUSTOMER COMPLAINTS FOR THIS FACILITY.

    Description of Event or Problem · 1

    THE OPERATOR WAS LOADING A BIOLOGICAL INDICATOR INTO A CENTURY STEAM STERILIZER (16" PREVAC). THE OPERATOR WITH HER BARE HANDS WAS TRYING TO PLACE THE INDICATOR DIRECTLY ON THE RACK INSIDE THE STERILIZATION CHAMBER BESIDE/BETWEEN THE SHELVES. THE OPERATOR CLAIMS THAT A BURST OF STEAM ENTERED THE CHAMBER AND BURNED HER HAND. THERE WERE NO WITNESSES TO THIS INCIDENT. THE INJURED OPERATOR WAS SEEN IN THE HOSPITAL'S EMERGENCY ROOM AND TRANSFERRED TO THE HOSPITAL'S BURN UNIT. SKIN GRAFT SURGERY FOR THE OPERATOR WAS SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention