BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2832343 · Received November 14, 2012

    Report

    Report Number
    3000251274-2012-00245
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 14, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS IDENTIFIED THROUGH A PRODUCTION/POST PRODUCTION RISK MANAGEMENT REVIEW THAT PROPERTY DAMAGE CAN OCCUR IF A SYSTEM 1E HOSE DISCONNECTS, RESULTING IN WATER LEAKAGE WHEN THE UNIT IS LEFT ON AND UNATTENDED AT NIGHT AND/OR WEEKENDS. STERIS HAS RECEIVED NO REPORTS OF INJURIES ASSOCIATED WITH THE DISCONNECTION OF A SYSTEM 1E WATER HOSE. THE STERIS SERVICE TECHNICIAN HAS INSTALLED NEW HOSES AND CONNECTIONS ON THIS SYSTEM 1E PROCESSOR (FIELD CORRECTION #3000251274-7/10/2012-001-C). THE TECHNICIAN TESTED THE UNIT, INCLUDING RUNNING A DIAGNOSTIC AND PROCESSING CYCLE AND CONFIRMED THE UNIT WAS OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A HOSE SEPARATED FROM THE SYSTEM 1E PROCESSOR, CAUSING WATER TO FLOW ONTO THE FLOOR WHERE THE SYSTEM WAS LOCATED. FACILITY PERSONNEL SHUT OFF THE WATER SUPPLY. NO INJURIES, PROCEDURAL DELAYS, PROPERTY DAMAGE 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