BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2803280 · Received October 24, 2012

    Report

    Report Number
    3000251274-2012-00230
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS IDENTIFIED THROUGH A PRODUCTION/POST PRODUCTION RISK MANAGEMENT REVIEW THAT PROPERTY DAMAGE CAN OCCUR IF A SYSTEM 1E HOSE DISCONNECTS, RESULTING IN WATER LEAKAGE WHEN THE UNIT IS LEFT ON AND UNATTENDED AT NIGHT AND/OR WEEKENDS. STERIS HAS RECEIVED NO REPORTS OF INJURIES ASSOCIATED WITH THE DISCONNECTION OF A SYSTEM 1E WATER HOSE. THE STERIS SERVICE TECHNICIAN HAS INSTALLED NEW HOSES AND CONNECTIONS ON THIS SYSTEM 1E PROCESSOR ((B)(4)). THE TECHNICIAN TESTED THE UNIT, INCLUDING RUNNING A DIAGNOSTIC AND PROCESSING CYCLE AND CONFIRMED THE UNIT WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER SPRAYED OUT OF A HOSE FITTING ONTO THE FLOOR FROM THE SYSTEM 1E PROCESSOR. THE USER FACILITY STAFF TURNED OFF THE WATER SUPPLY. WATER LEAKED INTO THREE ROOMS, THE ADJACENT HALLWAY AND INTO THREE ROOMS BELOW. NO INJURIES WERE REPORTED. NO PROCEDURES WERE DELAYED OR CANCELED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1