BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2883668 · Received December 21, 2012

    Report

    Report Number
    3000251274-2012-00276
    Date Received
    December 21, 2012
    Date of Event
    December 7, 2012
    Report Date
    December 21, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND TURNED ON THE WATER SUPPLY AND OBSERVED A FINE WATER SPRAY EMANATING OUT FROM THE 90 DEGREE FACTORY CRIMPED FITTING, SPECIFICALLY FROM THE CRIMPED END OF THE HOSE. THE TECHNICIAN REPLACED THE HOSE WITH NEW URETHANE DOUBLE 90 DEGREE FACTORY CRIMPED HOSE. THE TECHNICIAN RAN A DIAGNOSTIC AND PROCESSING CYCLE AND FOUND THE UNIT TO BE OPERATIONAL. THE TECHNICIAN STATED THAT THE FILTER HOUSING WAS INSTALLED WITH AN INCORRECT HOSE. STERIS QUALITY REQUESTED THAT THE TECHNICIAN ENSURE THAT ANY INSTALLED FILTER HOUSING BE MADE WITH URETHANE HOSES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WATER WAS LEAKING FROM THEIR SYSTEM 1E. THE AMOUNT OF WATER COVERED A SHELF IN THE CABINET AND THE FLOOR OF THE ROOM WHERE THE SYSTEM 1E IS LOCATED. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE 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