BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2860848 · Received December 6, 2012

    Report

    Report Number
    3000251274-2012-00259
    Date Received
    December 6, 2012
    Date of Event
    November 11, 2012
    Report Date
    December 6, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THEIR SYSTEM 1E WAS "HEAVILY" LEAKING WATER CAUSING PROPERTY DAMAGE. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS 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