BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 6310488 · Received February 8, 2017

    Report

    Report Number
    9680353-2017-00012
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 4, 2017
    Report Date
    February 8, 2017
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY STATED THE EMPLOYEE SUBJECT OF THE REPORTED EVENT ATTEMPTED TO MANUALLY DISPOSE OF AN S40 STERILANT CUP AFTER IT WAS OBSERVED THAT RESIDUAL FLUID REMAINED IN THE BOTTOM OF THE CONTAINER. THE USER FACILITY STATED THAT THE EMPLOYEE SUBJECT OF THE REPORTED EVENT IMPROPERLY INSERTED THE ASPIRATOR PROBE INTO THE S40 STERILANT CONTAINER AND EXPERIENCED IRRITATION FROM THE REMAINING FLUID IN THE CONTAINER. THE EMPLOYEE THEN DISPOSED OF THE S40 CONTAINER IN THE GARBAGE. THE OPERATOR MANUAL STATES ON PAGE (7-13) "WARNING: ALWAYS VERIFY THAT THE STERILANT CONTAINER IS EMPTY AT THE COMPLETION OF THE CYCLE." THE SYSTEM 1E OPERATOR MANUAL (3-4) CONTAINS INSTRUCTIONS FOR DISPOSING OF PARTIALLY FILLED CONTAINERS AND STATES AUTOMATED DISPOSAL BY USING THE PROCESSOR IS THE PREFERRED METHOD. A STERIS SERVICE TECHNICIAN ARRIVED ON SITE, INSPECTED THE SYSTEM 1E PROCESSOR, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE CYCLE PRECEDING THE REPORTED EVENT COMPLETED SUCCESSFULLY. THE STERIS SERVICE TECHNICIAN IDENTIFIED THE ROOM IN WHICH THE SYSTEM 1E IS LOCATED IS PROPERLY VENTILATED AND NO UNUSUAL ODOR WAS DETECTED AT ARRIVAL OR DURING THE SERVICE VISIT. THE TECHNICIAN INSPECTED THE ASPIRATOR PROBE AND FOUND IT TO BE IN WORKING CONDITION AND DID NOT REQUIRE REPLACEMENT. THE TECHNICIAN RETURNED THE SYSTEM 1E PROCESSOR TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. STERIS HAS MADE MULTIPLE ATTEMPTS TO OFFER IN-SERVICE TRAINING TO THE USER FACILITY ON THE PROPER USE OF THE SYSTEM 1E PROCESSOR AND THE PROPER DISPOSAL METHODS OF THE S40 STERILANT HOWEVER, THE USER FACILITY HAS NOT RESPONDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE EXPERIENCED IRRITATION AFTER MANUALLY DISPOSING OF AN S40 STERILANT CONTAINER. THE EMPLOYEE WENT TO THE HOSPITAL'S ER DEPARTMENT FOR EXAMINATION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95138 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other