BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2199985 · Received August 10, 2011

    Report

    Report Number
    3000251274-2011-00028
    Date Received
    August 10, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 10, 2011
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2011 THE USER FACILITY REPORTED EXPERIENCING AN ABORTED CYCLE DUE TO WATER TEMPERATURES NOT REACHING SPECIFICATION. A STERIS SERVICE TECHNICIAN INSPECTED THE USER FACILITY'S PROCESSOR AND FOUND THE LS1 SWITCH HAD BEEN TRIPPED, SUBSEQUENTLY PREVENTING THE HEATER ASSEMBLY FROM RAISING THE WATER TEMPERATURE TO SPECIFICATION. AT THE TIME OF THE SERVICE TECHNICIAN'S INSPECTION FOR THE (B)(6) 2011 EVENT, THE CUSTOMER REPORTED EXPERIENCING UV LIGHT TIMEOUT ALARMS. THE SERVICE TECHNICIAN OBTAINED A WATER SAMPLE FROM THE FACILITY WHICH WAS ANALYZED TO EVALUATE THE USER FACILITY'S INCOMING WATER QUALITY. THE RESULTS OF THIS ANALYSIS INDICATED THAT THE USER FACILITY'S HOT WATER HEATER IS IN NEED OF IMMEDIATE SERVICING BECAUSE CORROSION IN THE HOT WATER HEATER IS CONTRIBUTING TO POOR INCOMING WATER QUALITY TO THE SYSTEM 1E PROCESSOR. AS A RESULT, THE INCOMING WATER DOES NOT MEET THE MINIMUM WATER QUALITY SPECIFICATIONS FOR USE IN SYSTEM 1E. THE WATER QUALITY SPECIFICATIONS FOR THE SYSTEM 1E ARE INDICATED WITHIN THE SITE PREPARATION AND INSTALLATION GUIDE AND WERE A REQUIREMENT FOR THE CUSTOMER TO VERIFY PRIOR TO INSTALLATION OF A SYSTEM 1E. THIS TYPE OF WATER QUALITY ISSUE IS THE OBJECT OF A VOLUNTARY FIELD ACTION INITIATED BY STERIS CORPORATION ((B)(4)). AS PART OF THIS FIELD ACTION, STERIS WILL COLLECT WATER SAMPLES FROM FACILITIES EXPERIENCING UV LIGHT ALARMS TO ENSURE THAT THE FACILITY'S INCOMING WATER MEETS THE MINIMUM SPECIFIED WATER QUALITY. THE SERVICE TECHNICIAN REPLACED THE LS1 SWITCH, AS WELL AS INSTALLED AN IN-LINE CARBON FILTER TO ADDRESS THE POOR INCOMING WATER QUALITY. HE SUCCESSFULLY TESTED THE UNIT AND RETURNED IT TO SERVICE. THE SYSTEM 1E HAS BEEN OPERATING PROPERLY WITH NO ADDITIONAL ISSUES. THE USER FACILITY REPORTED THAT THEY WILL BE RELOCATING THEIR SYSTEM 1E PROCESSOR TO A NEW LOCATION WITHIN THEIR FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT PATIENT PROCEDURES WERE RESCHEDULED AS A RESULT OF THEIR SYSTEM 1E PROCESSOR NOT OPERATING PROPERLY. THE PATIENT PROCEDURES WERE SUCCESSFULLY RESCHEDULED AND COMPLETED.

    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