BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 6708583 · Received July 12, 2017

    Report

    Report Number
    9680353-2017-00057
    Event Type
    Malfunction
    Date Received
    July 12, 2017
    Date of Event
    June 12, 2017
    Report Date
    July 12, 2017
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DELAY OCCURRED AS A RESULT OF THE REPORTED EVENT. DURING THE TIME OF THE EVENT, AN EMPLOYEE INITIATED A PROCESSING CYCLE AND OBSERVED FLUID LEAKING FROM THE FRONT OF THE UNIT ONTO THE COUNTERTOP AND WORK ROOM FLOOR. THE EMPLOYEE CANCELLED THE CYCLE AND BEGAN TO CLEAN UP THE WATER THAT LEAKED ONTO THE FLOOR WHEN FLUID SPLASHED ONTO THE EMPLOYEE'S HAND CAUSING THE REPORTED BURN. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WASHED THEIR HANDS, SOUGHT MEDICAL ASSESSMENT AT A NEARBY OUTPATIENT CLINIC, AND RETURNED TO WORK. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE SYSTEM 1E AND OBSERVED WATER ON THE COUNTERTOP AND TOWELS ON THE FLOOR AROUND THE UNIT. THE TECHNICIAN FOUND THAT CHECK VALVES 2 AND 3 WERE STUCK CLOSED. THIS CREATED AN AIR PRESSURE CONDITION INSIDE THE CHAMBER CAUSING AIR AND WATER TO PUSH PAST THE SEAL BETWEEN THE TOP OF THE TRAY AND LID SEAL. THE TECHNICIAN REPLACED THE FLOAT BLOCK ASSEMBLY WHICH CONTAINS CHECK VALVES 2 AND 3, RAN A DIAGNOSTIC AND PROCESSING CYCLE, AND FOUND THE SYSTEM 1E OPERATIONAL. THE SYSTEM 1E IS UNDER SERVICE CONTRACT AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE OBTAINED A BURN WHILE CLEANING UP A WATER LEAK FROM THEIR SYSTEM 1E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490089 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1