BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 3140185 · Received May 31, 2013

    Report

    Report Number
    3000251274-2013-00050
    Date Received
    May 31, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 31, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE CYCLE PRINTOUT AND FOUND THAT THE CYCLE COMPLETED SUCCESSFULLY. THE TECHNICIAN FURTHER INSPECTED THE ASPIRATOR PROBE ASSEMBLY AND FOUND NO ISSUE. THE EMPLOYEE SUBJECT OF THE REPORTED EVENT WAS NOT WEARING PROPER PPE AS STATED IN THE OPERATOR MANUAL THE OPERATOR MANUAL STATES (PP.1-3), "APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE) IS REQUIRED WHEN HANDLING CONTAINERS OF S40 STERILANT CONCENTRATE. MINIMALLY, PPE SHOULD CONSIST OF CHEMICAL-RESISTANT GLOVES, APRON, GOGGLES OR FACE SHIELD, AND ANY OTHER PROTECTION REQUIRED BY THE FACILITY PROCEDURES". STERIS CONDUCTED IN-SERVICE ON (B)(4) 2013 ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E AND PROPER PPE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AFTER A COMPLETED CYCLE AN EMPLOYEE OPENED THE LID OF THE SYSTEM 1E TO REMOVE THE S40 STERILANT CONTAINER FROM THE TRAY AND RESIDUAL LIQUID CONTACTED HIS FACE. THE EMPLOYEE FLUSHED HIS FACE WITH COLD WATER AND WAS SENT TO THE ER. AT THE ER HE WAS GIVEN A STANDARD VISION AND ABRASION TEST. THE EMPLOYEE PASSED THE EYE EXAMINE AND NO ABRASIONS WERE NOTED. THE EMPLOYEE FLUSHED HIS EYES AGAIN AND WAS SENT HOME FOR THE REMAINDER OF THE DAY. THE EMPLOYEE IS FINE WITH NO SUSTAINING INJURIES. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241643 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1