BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2974227 · Received February 22, 2013

    Report

    Report Number
    3000251274-2013-00020
    Date Received
    February 22, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 22, 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 INSPECTED THE UNIT AND FOUND A SEPARATED HOSE WITH A 90 DEGREE FACTORY CRIMP FITTING INSTALLED TO THE BIG BLUE HOUSING INLET CONNECTION. THE TECHNICIAN CUT OFF THE END OF THE HOSE, SLIPPED IT OVER THE 90 DEGREE FITTING AND TIGHTENED DOWN WITH A WORM CLAMP. A STERIS SERVICE TECHNICIAN RETURNED TO THE USER FACILITY A FEW DAYS LATER AND OBSERVED THE WATER PRESSURE GAUGE TO READ OVER 100 PSI AND ADVISED THE USER FACILITY THAT THE BIG BLUE HOUSING IS RATED FOR A MAXIMUM OF 90PSI AND REQUESTED THEY LOWER THE PRESSURE. THE TECHNICIAN REPAIRED THE UNIT, RAN A DIAGNOSTIC AND PROCESSING CYCLE AND CONFIRMED THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A HOSE SEPARATED FROM THE UNIT CAUSING A LARGE AMOUNT OF WATER TO LEAK OUT ONTO THE FLOOR. THE USER FACILITY CLEANED UP THE WATER AND CONTACTED STERIS. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78493 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1