BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2860987 · Received December 6, 2012

    Report

    Report Number
    3000251274-2012-00254
    Date Received
    December 6, 2012
    Date of Event
    November 7, 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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECHNICIAN INSPECTED THE UNIT AND FOUND THAT THE UREBRADE HOSE SEPARATED OFF THE STRAIGHT BARB FITTING INSTALLED TO THE PRE A&B FILTER INLET ADAPTER. THE TECHNICIAN FURTHER INSPECTED THE UNIT AND FOUND THE HOSE AND WORM CLAMP TO BE IN GOOD CONDITION. THE TECHNICIAN STATED THAT THE FACILITY PLUMBER TOLD HIM THAT THEIR PRESSURE WAS APPROXIMATELY 90PSI AND THE FACILITY WAS UNDERGOING SOME RENOVATION WORK. THE TECHNICIAN HAD OBSERVED THAT THE FACILITY HAD INSTALLED A PRESSURE REGULATOR BEFORE THEIR BIG BLUE HOUSING. THE PRESSURE REGULATOR WAS INSTALLED AFTER THE REPORTED EVENT AND PRIOR TO THE STERIS SERVICE TECHNICIAN'S ARRIVAL. THE TECHNICIAN REINSTALLED THE HOSE BY SLIPPING IT OVER THE BARBED FITTING AND TIGHTENED IT DOWN WITH A WORM CLAMP. THE TECHNICIAN TESTED THE UNIT BY RUNNING A DIAGNOSTIC AND PROCESSING CYCLE AND FOUND THE UNIT TO BE OPERATIONAL.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A HOSE SEPARATED ON THE SYSTEM 1E CAUSING WATER TO FLOW OUT ONTO THE FLOOR IN THE ROOM WHERE THE UNIT IS LOCATED AND INTO THE FLOOR BELOW. 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