BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3232632 · Received July 18, 2013

    Report

    Report Number
    3000251274-2013-00062
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 17, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND THE USER FACILITY STATED THAT THE LEAK OCCURRED DURING A DIAGNOSTIC CYCLE AND THAT WATER WAS COMING FROM THE FRONT PART OF THE LID. THE EMPLOYEE HAD TURNED OFF THE WATER SUPPLY AND CONTACTED THE USER FACILITY'S BIOMEDICAL DEPARTMENT. THE BIOMED AND JANITORIAL SERVICES CLEANED UP THE WATER. THE STERIS SERVICE TECHNICIAN INSPECTED THE CYCLE PRINTOUT SUBJECT OF THE REPORTED EVENT AND FOUND THAT THE CYCLE FAULTED DUE TO A FILL TIMEOUT. THE TECHNICIAN RAN A DIAGNOSTIC CYCLE AND FOUND THE UNIT TO BE OPERATING PROPERLY. THE TECHNICIAN ADVISED THE USER FACILITY TO USE CARE WHEN LOADING THE TRAYS. STERIS IS SCHEDULED TO PERFORM IN-SERVICE TRAINING ON 7/18/2013 ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333869 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1