BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3021576 · Received March 26, 2013

    Report

    Report Number
    3000251274-2013-00027
    Date Received
    March 26, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 26, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY AND COULD NOT DETERMINE THE VOLUME OF THE SPILL AS IT WAS CLEANED UP PRIOR TO HIS ARRIVAL. THE TECHNICIAN INSPECTED THE UNIT AND DISCOVERED THE DRAIN HOSE WAS NOT IN THE STANDPIPE WHICH CAUSED FLUID TO DRAIN DIRECTLY TO THE FLOOR. THE SYSTEM 1E AT THIS FACILITY IS LOCATED ON A CART WHICH WAS PRESUMABLY MOVED FOR CLEANING PURPOSES. THE STAFF MEMBER WHO MOVED THE UNIT DID NOT PLACE THE HOSE BACK INTO THE STANDPIPE WHICH ALLOWED THE USED DILUTION TO DRAIN ONTO THE FLOOR. THE TECHNICIAN RE-INSERTED THE DRAIN HOSE, TESTED THE UNIT AND CONFIRMED THE UNIT OPERATIONAL. THE TECHNICIAN EDUCATED THE STAFF ON THE IMPORTANCE OF RE-INSERTING THE DRAIN HOSE INTO THE STANDPIPE AFTER MOVING THE UNIT.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THEIR SYSTEM 1E UNIT WAS LEAKING USED DILUTION FROM THE BACK OF THE UNIT. THERE WERE NO PROCEDURAL DELAYS/CANCELLATIONS OR INJURIES ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123598 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other