BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2920957 · Received January 17, 2013

    Report

    Report Number
    3000251274-2013-00004
    Date Received
    January 17, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED TO THE STERIS SERVICE TECHNICIAN THAT A SMALL DRIP OF WATER WAS OBSERVED COMING FROM THE UNIT. THE USER FACILITY CONTACTED THEIR BIOMED CONTRACTOR TO COME IN AND SERVICE THE UNIT. THE DRIP WAS OBSERVED AT THE A & B FILTER INLET BARB CONNECTOR. DURING REPAIR OF THE UNIT, THE BIOMED CONTRACTOR OVER-TIGHTENED THE FITTING AND CUT THROUGH THE GASKET. THIS CAUSED THE LEAK RATE AND SIZE TO INCREASE. BIOMED IMMEDIATELY SHUT OFF WATER SUPPLY TO THE UNIT AND CLEANED UP THE WATER. THE FACILITY THEN CONTACTED STERIS. THE STERIS TECHNICIAN REMOVED THE BARB CONNECTOR AND CONFIRMED THE GASKET HAD BEEN CUT. THE GASKET/O-RING OF THE INLET HOSE WAS REPLACED AND RECONNECTED WITH THE FITTING. THE SERVICE TECHNICIAN RAN A DIAGNOSTIC AND PROCESSING CYCLE AND THE UNIT WAS CONFIRMED TO BE OPERATIONAL. THE SERVICE TECHNICIAN ALSO DISCUSSED WITH THE FACILITY THE IMPORTANCE OF PROPER TIGHTENING OF THE A/B FILTER ASSEMBLY CONNECTIONS AND ADVISED CONTACTING STERIS FOR ANY SERVICE REQUESTS ON STERIS PRODUCTS IN THE FUTURE.

    Description of Event or Problem · 1

    USER FACILITY REPORTED A SMALL DRIP COMING FROM THE SYSTEM 1 E. NO INJURIES TO HOSPITAL STAFF OR PATIENTS. NO PROCEDURAL DELAYS OR CANCELLATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27144 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1