BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2840770 · Received November 20, 2012

    Report

    Report Number
    3000251274-2012-00249
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND OBSERVED AN ESTIMATED 3 GALLONS OF WATER HAD LEAKED FROM THE SYSTEM 1E PROCESSOR. THE TECHNICIAN TURNED ON THE WATER SUPPLY AND OBSERVED A LEAK LOCATED AT THE 90 DEGREE FACTORY CRIMP FITTING FEMALE SWIVEL INSTALLED TO THE UV OUTLET PORT. THE TECHNICIAN INSPECTED THE SWIVEL AND FOUND IT WAS NOT FULLY TIGHTENED ONTO THE PORT. THE FITTING ITSELF WAS NOT DAMAGED. THE LEAK IS ATTRIBUTED TO INADEQUATE TIGHTENING OF THE CONNECTION DURING PRIOR SERVICE ACTIVITY. THE TECHNICIAN WILL BE RETRAINED ON THE PROPER INSTALLATION PROCEDURE. TWO DIAGNOSTIC CYCLES WERE COMPLETED AND THE UNIT WAS FOUND OPERATIONAL. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR SYSTEM 1E PROCESSOR WAS LEAKING WATER OUT ONTO THE FLOOR WHERE THE UNIT WAS LOCATED. USER FACILITY PERSONNEL SHUT OFF THE WATER SUPPLY AND SERVICE WAS CALLED. NO PROCEDURAL DELAYS/CANCELLATIONS OR INJURIES WERE REPORTED. 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