BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2851451 · Received November 29, 2012

    Report

    Report Number
    3000251274-2012-00253
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN INSPECTED THE EQUIPMENT, AND FOUND THE RUBBER WASHER IN THE 90 DEGREE FACTORY CRIMP FITTING AT THE UV ASSEMBLY CONNECTION WAS CUT THROUGH. THE TECHNICIAN REPLACED THE WASHER, AND RETHREADED THE HOSE FITTING ONTO THE ADAPTER. THE UNIT WAS TESTED, FOUND TO BE OPERATIONAL AND RETURNED TO SERVICE. THE CAUSE OF THE LEAK WAS A CUT RUBBER WASHER INSIDE OF THE HOSE FITTING. THIS DAMAGE WAS CAUSED BY OVER-TIGHTENING OF THE HOSES ON THE UV ASSEMBLY CONNECTION. THE STERIS SERVICE TECHNICIAN WHO MAINTAINED THE UNIT ON (B)(4) 2012 WAS CAUTIONED TO NOT OVER-TIGHTEN THE HOSES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A LEAK AT THE UV LIGHT HOSE CONNECTIONS. WATER COVERED THE COUNTER AND THE FLOOR, APPROXIMATELY 8 X 10 FEET. THE LEAK OCCURRED DURING THE NIGHT, AND WAS DISCOVERED THE NEXT MORNING. THE CUSTOMER TURNED OFF THE WATER UPON DISCOVERING THE LEAK. NO INJURIES WERE REPORTED. NO PROCEDURES WERE DELAYED OR CANCELLED.

    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