BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3874969 · Received June 16, 2014

    Report

    Report Number
    3000251274-2014-00050
    Date Received
    June 16, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 16, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SYSTEM 1E UNIT. THE TECHNICIAN RAN A DIAGNOSTIC CYCLE AND PROCESSING CYCLE WITH A CHEMICAL INDICATOR (CI) PRESENT. BOTH CYCLES AND THE CI PASSED SUCCESSFULLY. NO ISSUES WERE NOTED WITH THE PROCESSOR AND IT WAS RETURNED TO SERVICE. FOLLOWING THE STERIS TECHNICIAN'S ONSITE VISIT, A STERIS CLINICAL EDUCATION SPECIALIST AND STERIS ACCOUNT MANAGER VISITED THE FACILITY TO OBSERVE ITS SCOPE CLEANING AND PROCESSING PROCESSES. THEY LEARNED THAT AFTER SCOPES WERE PROCESSED IN THE SYSTEM 1E THEY WERE HUNG IN STORAGE FOR UP TO TWO DAYS PRIOR TO USE. THE STERIS CLINICAL EDUCATION SPECIALIST AND STERIS ACCOUNT MANAGER IMMEDIATELY PERFORMED IN-SERVICE TRAINING AND EMPHASIZED THAT SCOPES CANNOT BE STORED IN THIS MANNER FOLLOWING PROCESSING, AND PRIOR TO USE. SCOPES MUST BE USED IMMEDIATELY AFTER BEING PROCESSED IN SYSTEM 1E AS STATED IN THE SYSTEM 1E OPERATOR MANUAL. THE OPERATOR MANUAL STATES (PP. 7-14), "DEVICES NOT USED IMMEDIATELY MUST BE LIQUID CHEMICALLY RE-STERILIZED PRIOR TO PATIENT USE." FOLLOW UP CONVERSATION WITH THE CUSTOMER CONCLUDED THAT NO FURTHER ISSUES HAVE BEEN REPORTED. STERIS HAS SCHEDULED AN ADDITIONAL IN-SERVICE TRAINING IN (B)(6) AT THE FACILITY.

    Description of Event or Problem · 1

    THE USER FACILITY CONTACTED STERIS IN REGARDS TO AN INVESTIGATION WHICH INCLUDED INSPECTION OF THEIR SYSTEM 1E PROCESSOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353380 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other