BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANCE EPS

    MDR report key: 1699392 · Received May 26, 2010

    Report

    Report Number
    3000251274-2010-00016
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    April 23, 2010
    Report Date
    May 26, 2010
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    NZA
    PMA / PMN Number
    K040049
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE RELIANCE EPS AND WAS UNABLE TO DUPLICATE THE REPORTED EVENT. THE USER FACILITY REPORTED THAT THE EMPLOYEE WAS NOT WEARING PPE (PERSONAL PROTECTIVE EQUIPMENT) DURING THE REPORTED EVENT. THE SERVICE TECHNICIAN TESTED THE WASHER BY RUNNING SEVERAL CYCLES SUCCESSFULLY, VERIFYING PROPER OPERATION, AND RETURNED THE UNIT TO SERVICE. THE WASHER IS NOT UNDER STERIS SERVICE CONTRACT AND IS MAINTAINED BY A THIRD PARTY PROVIDER. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE DEVICE. STERIS HAS DETERMINED THE ROOT CAUSE OF THIS EVENT TO BE USER ERROR AS THE HOSPITAL EMPLOYEE REMOVED A FULL DRY CHEMISTRY CUP THAT WAS INSERTED AND READY FOR USE AND DID NOT WEAR PROPER PPE. THE RELIANCE EPS OPERATOR MANUAL INSTRUCTS USERS THAT "ONCE THE RELIANCE DRY CHEMISTRY CONTAINER IS INSERTED, CLOSE AND LATCH THE RELIANCE CDS." (B)(4) THE OPERATOR MANUAL FURTHER WARNS USERS THAT "BEFORE OPENING PROCESSOR DOOR MANUALLY, WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE). ALLOW PROCESSOR TO COOL DOWN. AVOID INHALING FUMES FROM CHAMBER AND CONTACT WITH ANY REMAINING SOLUTION" (B)(4). THE HOSPITAL REPORTED THAT THE EMPLOYEE SUBJECT OF THIS EVENT HAS BEEN COUNSELED ON MULTIPLE OCCASIONS FOR NOT WEARING PROPER PPE. STERIS COMPLETED A REFRESHER IN-SERVICE TRAINING ON MAY 14, 2010 REGARDING THE PROPER USE AND OPERATION OF THE DEVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A HOSPITAL EMPLOYEE REMOVED A FULL DRY CHEMISTRY CUP FROM A RELIANCE (EPS) THAT HAD BEEN INSERTED FOR USE IN A HIGH LEVEL DISINFECTION CYCLE WHEN DRY POWDER CAME OUT OF THE BOTTOM OF THE CUP AND IN CONTACT WITH THE EMPLOYEE'S RIGHT ARM. THE EMPLOYEE RAN HER ARM UNDER WATER FOR FIFTEEN MINUTES AND THEN REPORTED TO THE FACILITY EMERGENCY ROOM WHERE SHE WAS TREATED FOR REDNESS AND BURNING AND RECEIVED AN IV AND WENT HOME. THE HOSPITAL EMPLOYEE REPORTS THAT SHE HAS FULLY HEALED, IS BACK AT WORK, AND HAS HAD NO RESIDUAL INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE EPS RELIANCE EPS NZA STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other