BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL LOADING CART

    MDR report key: 2113791 · Received June 3, 2011

    Report

    Report Number
    9680353-2011-00013
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 3, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE REPRESENTATIVE INSPECTED THE TRANSFER CART AND FOUND IT WAS OPERATING PROPERLY. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. THE CART IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED BY THE USER FACILITY. THE USER FACILITY ACKNOWLEDGED THE EVENT WAS DUE TO USER ERROR AS THE OPERATOR ATTEMPTED TO DISLODGE THE BUCKET WHILE THE PROCESSED LOAD WAS STILL HOT. ADDITIONALLY, THE BUCKETS WERE NOT PROPERLY LOADED AS THEY ARE LIGHT WEIGHT AND FLIP DURING CYCLES, COLLECTING RESIDUAL WATER. THE WASHER OPERATOR MANUAL STATES (PP.-4-28): "LEAVE DOOR OPEN TO ALLOW LOAD TO COOL BEFORE REMOVING ACCESSORY RACK OR BASKET." THE MANUAL FURTHER STATES (PP. 4-21): "WHEN LOADING A BASKET, BOWLS MUST BE PLACED OPEN END DOWN IN BASKET. IF LIGHTWEIGHT PLASTICWARE OR METALWARE IS BEING WASHED, USE A COVER TO PREVENT ITEMS FROM TURNING." STERIS CONDUCTED IN-SERVICE TRAINING REGARDING THE PROPER USE AND OPERATION OF THE EQUIPMENT ON (B)(4), 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A BUCKET WAS STUCK ON THE SPRAY ARM OF THE MANIFOLD RACK WHEN THE OPERATOR WAS REMOVING THE TRANSFER CART AFTER A COMPLETED CYCLE. WHEN THE OPERATOR MANUALLY ATTEMPTED TO REMOVE THE STUCK BUCKET BY PULLING ON IT, THE BUCKET FULL OF RESIDUAL WATER TIPPED AND THE MANIFOLD CAME TOWARDS THE OPERATOR RESULTING IN BOTH THE HOT MANIFOLD AND RESIDUAL WATER CONTACTING HER ARM. THE OPERATOR WENT TO THE FACILITY EMERGENCY ROOM WHERE SHE RECEIVED A TETANUS SHOT AND SILVADENE CREAM AND A BANDAGE WAS APPLIED TO THE BURN. THE USER FACILITY REPORTED THE EMPLOYEE IS FINE WITH NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIVERSAL LOADING CART LOADING/TRANSFER CART LDS STERIS CANADA CORPORATION 4011085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other