BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2946293 · Received February 6, 2013

    Report

    Report Number
    3000251274-2013-00015
    Date Received
    February 6, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND COULD NOT DETERMINE THE VOLUME OF WATER THAT HAD LEAKED AS IT WAS CLEANED PRIOR TO HIS ARRIVAL. THE TECHNICIAN ESTIMATED THE WATER TO HAVE COME OUT ONTO 20 SQUARE FEET OF FLOORING AND 10 SQUARE FEET OF COUNTERTOP. A SLOW DRIP, ESTIMATED AT A RATE OF ONE DRIP EVERY 5 SECONDS, WAS DISCOVERED AT 3 OUT OF 4 OF THE UV PORTS CONNECTED TO THE SYSTEM 1E UNITS. UPON INSPECTION, THE TECHNICIAN FOUND THE 90 DEGREE HOSE FITTINGS LOOSE. THE HOSE FITTINGS WERE PROPERLY TIGHTENED, A DIAGNOSTIC CYCLE WAS SUCCESSFULLY COMPLETED FOR EACH PROCESSOR AND THE UNITS WERE PUT BACK INTO OPERATION. THE LEAK IS ATTRIBUTED TO UNDER-TIGHTENING OF THE UV CONNECTIONS DURING PRIOR SERVICE ACTIVITY. STERIS QUALITY DISCUSSED THE IMPORTANCE OF PROPER TIGHTENING OF THE SYSTEM 1E HOSE CONNECTIONS WITH THE TECHNICIAN.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR SYSTEM 1E UNITS ONTO THE COUNTERTOP AND SPILLING ONTO THE FLOOR. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50120 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1