BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3813147 · Received May 15, 2014

    Report

    Report Number
    3000251274-2014-00039
    Date Received
    May 15, 2014
    Date of Event
    April 24, 2014
    Report Date
    May 15, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN DISCUSSED THE REPORTED EVENT WITH AN EMPLOYEE WHO STATED THEY INITIATED A DIAGNOSTIC CYCLE AND LEFT THE ROOM. WHEN THE EMPLOYEE RETURNED A SIGNIFICANT AMOUNT OF WATER WAS ON THE FLOOR OF THE ROOM. THE EMPLOYEE CANCELLED THE CYCLE AND TURNED OFF THE WATER TO THE UNIT. THERE WAS APPROXIMATELY TWO GALLONS OF WATER ON THE FLOOR AND WAS CLEANED UP BY THE MAINTENANCE DEPARTMENT. THE EMPLOYEE OPENED THE LID AND OBSERVED THAT PART OF THE ASPIRATOR AND HOSE WAS WEDGED IN-BETWEEN THE INFLATABLE SEAL AND TRAY. THE STERIS TECHNICIAN INFORMED THE EMPLOYEE TO INSPECT THE ASPIRATOR AND TUBING; NO ISSUES WERE NOTED. THE TECHNICIAN RECOMMENDED THE ASPIRATOR BE REPLACED AS A PRECAUTION. THE TECHNICIAN DISCUSSED WITH THE EMPLOYEE THE IMPORTANCE OF THE ASPIRATOR AND TUBING BEING PLACED IN THE CUP-WELL BEFORE THE LID IS CLOSED AND A DIAGNOSTIC CYCLE IS INITIATED. THE EMPLOYEE PERFORMED TWO DIAGNOSTIC CYCLES AND CONFIRMED THE PROCESSOR TO BE OPERATING TO SPECIFICATION; NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR SYSTEM 1E PROCESSOR. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291303 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1