BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2241837 · Received September 9, 2011

    Report

    Report Number
    3000251274-2011-00036
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    September 9, 2011
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE PROCEDURE WAS DELAYED DURING THE WEEK OF (B)(4), 2011. THE USER FACILITY DOES NOT KNOW THE EXACT DATE OF THE DELAY. DURING THE COURSE OF THE INVESTIGATION, IT WAS IDENTIFIED THAT THE USER FACILITY'S INCOMING WATER PRESSURE IS AT THE MINIMUM SPECIFICATION OF 40 PSIG. DUE TO THE INCOMING WATER PRESSURE OPERATING AT THE MINIMUM SPECIFICATION, WATER PRESSURE FLUCTUATIONS CAN RESULT IN THE PRESSURE DROPPING BELOW 40 PSIG, WHICH WILL CAUSE THE FILL TIME ISSUE REPORTED BY THE USER FACILITY. A SERVICE TECHNICIAN VISITED THE USER FACILITY ON (B)(4), 2011 TO RECOMMEND THAT THE FACILITY ADJUST THEIR INCOMING WATER PRESSURE HIGHER THAN THE MINIMUM SPECIFICATION TO ACCOUNT FOR WATER PRESSURE FLUCTUATIONS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED EXPERIENCING FILL TIME FAILURES SINCE THE INSTALLATION OF THEIR SYSTEM 1E PROCESSOR IN JUNE; A PATIENT PROCEDURE WAS DELAYED DUE TO UNAVAILABILITY OF THE INSTRUMENTS REQUIRED AS A RESULT OF THE SYSTEM 1E PROCESSOR NOT OPERATING PROPERLY.

    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 Other