BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2803284 · Received October 24, 2012

    Report

    Report Number
    3000251274-2012-00233
    Date Received
    October 24, 2012
    Date of Event
    September 23, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE EQUIPMENT AND OBSERVED THE HOSE BETWEEN THE BOOSTER HEATER AND 'BIG BLUE' FILTER HOUSING DISCONNECTED AT THE OUTLET ON THE BOOSTER HEATER. THE LEAK WAS ATTRIBUTED TO THE SHARP BEND IN THE HOSE WITHIN CLOSE PROXIMITY OF THE HEATER OUTLET. THE TECHNICIAN TESTED THE UNIT BY RUNNING DIAGNOSTIC AND PROCESSING CYCLES, AND FOUND THE UNIT OPERATIONAL. THE UNIT WAS RETURNED TO SERVICE. THIS CONNECTION IS THE RESPONSIBILITY OF THE CUSTOMER.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A WATER LEAK FROM THE SYSTEM 1E PROCESSOR, WHICH CAUSED WATER TO SPILL ONTO THE FLOOR OF THE GI LAB AND ADJACENT ROOMS. NO INJURIES WERE REPORTED. NO PROCEDURES WERE DELAYED OR CANCELLED. NO PROPERTY DAMAGE WAS REPORTED.

    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