BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3983583 · Received July 1, 2014

    Report

    Report Number
    3000251274-2014-00057
    Date Received
    July 1, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 1, 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 FACILITY EMPLOYEE OPENED THE LID OF THE SYSTEM 1E FOLLOWING A PROCESSING CYCLE WHICH HAD FAULTED. THE INSTRUMENT INCLUDED IN THE CYCLE WAS REPROCESSED BEFORE USE IN A PT PROCEDURE. UPON OPENING THE LID, THE EMPLOYEES IN THE ROOM REPORTED IRRITATION OF THE EYES AND EVACUATED THE AREA. A STERIS SERVICE TECH ARRIVED AT THE FACILITY AND UPON ENTERING THE ROOM WHERE THE SYSTEM 1E IS LOCATED DETECTED A FAINT ODOR. THE TECH RAN TEST DIAGNOSTIC AND PROCESSING CYCLE WHICH COMPLETED SUCCESSFULLY WITH NO FAULT. THE TECH WAS UNABLE TO DUPLICATE THE CYCLE FAULT AS THE FACILITY REPORTED. THE STERIS TECH OBSERVED THE ROOM WHERE THE SYSTEM 1E IS LOCATED HAD LITTLE VENTILATION. A STERIS ACCOUNT MGR CONTACTED THE USER FACILITY TO DISCUSS THE VENTILATION, SPECIFICALLY AAMI-ST 58 RECOMMENDATION OF 10 AIR EXCHANGES PER HR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE STERILANT SMELL FROM THE SYSTEM 1E WAS CAUSING THE OPERATING ROOM EMPLOYEES TO EXPERIENCE EYE IRRITATION. THE AFFECTED INDIVIDUALS DID NOT SEEK MEDICAL ATTENTION DUE TO THE SMELL, HOWEVER THE EMPLOYEES EVACUATED THE AREA WHERE THE SYSTEM 1E IS LOCATED. ONE INDIVIDUAL REPORTED EXPERIENCING A HEADACHE DUE TO THE SMELL AND WENT HOME FOR THE REMAINDER OF THE DAY. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385127 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYS MED STERIS CORPORATION-HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other