BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2946267 · Received February 6, 2013

    Report

    Report Number
    3000251274-2013-00014
    Date Received
    February 6, 2013
    Date of Event
    January 3, 2013
    Report Date
    February 6, 2013
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS ACCOUNT MANAGER INVESTIGATED THE EVENT, AND INTERVIEWED THE AFFECTED STAFF. THE EMPLOYEE STATED SHE PLACED THE S40 CONTAINER INTO THE PROCESSOR. SHE WAS NOT ABLE TO PUNCTURE THE CUP. SHE REMOVED THE UN-PUNCTURED CUP, PLACED THE CUP IN A SINK, TURNED THE CUP OVER (PLASTIC SIDE UP) AND CUT THE CONTAINER. WHEN THE CONTAINER WAS CUT THE CONTENTS SPILLED OUT ONTO HER. IN THE PROCESS OF DISPOSAL, SHE OBSERVED LIQUID CONTACT HER BARE ARMS AND SCRUB TOP. SHE FELT A BURNING SENSATION. THE EMPLOYEE WAS WEARING A FACE MASK AND GLOVES DURING DISPOSAL. THE STERIS ACCOUNT MANAGER STATED THAT PREVIOUS TO THE EVENT HE HAD OBSERVED FACILITY PERSONNEL USE EXCESSIVE FORCE TO PLACE S40 CUPS INTO THE PROCESSOR. HE HAS INSTRUCTED THEM NOT TO DO SO. THE SYSTEM 1E OPERATOR MANUAL STATES (ON PAGE 1-3): "DO NOT PUSH THE CONTAINER INTO THE STERILANT COMPARTMENT WITH EXCESSIVE FORCE. NEVER SLAM THE CONTAINER INTO THE STERILANT COMPARTMENT. DAMAGE TO THE CONTAINER MAY OCCUR." THE SYSTEM 1E OPERATOR MANUAL STATES (ON PAGE 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 FACILITY PROCEDURES." THE SYSTEM 1E OPERATOR MANUAL STATES (ON PAGE 3-5): "SUBMERGE THE STERILANT CONTAINER INTO THE BUCKET CONTAINING THE DISSOLVED POWDERS." A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT, RAN BOTH DIAGNOSTIC AND PROCESSING CYCLES AND FOUND NO ISSUES. THE CAUSE OF THE CHEMICAL CONTACT EVENT WAS DUE TO IMPROPER DISPOSAL OF S40 STERILANT, AND IMPROPER PPE WORN BY THE OPERATOR. THE FACILITY WILL BE OFFERED AN IN-SERVICE ON PROPER PPE AND MANUAL DISPOSAL INSTRUCTIONS.

    Additional Manufacturer Narrative · 1

    THE STERIS ACCOUNT MANAGER PROVIDED AN IN-SERVICE TO THE FACILITY ON PROPER PPE AND MANUAL DISPOSAL INSTRUCTIONS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE WAS MANUALLY DISPOSING OF AN S40 CUP, WHEN LIQUID CONTACTED HER ARMS AND SCRUB TOP.SHE RINSED THE AREAS AND WENT TO OCCUPATIONAL HEALTH. NO BLISTERING WAS REPORTED. NO MEDICAL TREATMENT WAS REPORTED. THE EMPLOYEE WENT HOME, TOOK A SHOWER, AND RETURNED TO WORK.NO PROCEDURAL DELAYS OR CANCELLATIONS HAVE BEEN REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50381 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other