BEUDAMED
    FDA Adverse Event Summary report: N

    1227 CART WASHER

    MDR report key: 4918604 · Received July 16, 2015

    Report

    Report Number
    9680353-2015-00044
    Date Received
    July 16, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 16, 2015
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    FLH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY MEDWATCH ALSO STATED THAT EMPLOYEE'S HANDS ARE GETTING CAUGHT BETWEEN THE CART AND DOOR WHEN UNLOADING. NO HANDLES ARE ATTACHED. A STERIS SERVICE TECHNICIAN INSPECTED THE WASHER AND CASE CART AND FOUND THEM TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED. THE WASHER AND CASE CART WERE RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED. CONTRARY TO THE FACILITY REPORT, THE TECHNICIAN CONFIRMED THE CASE CART'S HANDLES WERE ATTACHED TO THE UNIT. INSTEAD OF UTILIZING THE CASE CART HANDLES THE EMPLOYEE GRABBED THE TOP LEFT AND RIGHT SIDE OF THE CART TO REMOVE IT FROM THE WASHER. IN THE PROCESS OF REMOVING THE CASE CART THE EMPLOYEE INJURED HER FINGER BETWEEN THE WASHER DOOR AND CASE CART. THE EMPLOYEE WORE A SOFT BRACE AND MISSED NO TIME FROM WORK. THE USER FACILITY REPORTED THAT EMPLOYEES WERE SUSTAINING INJURIES, HOWEVER STERIS WAS MADE AWARE OF ONLY ONE EMPLOYEE INJURY IN RELATION TO THE REPORTED EVENT. HANDLES ON THE CASE CART ARE LOCATED ON ONE SIDE OF THE CASE. THE HANDLES ON THE CASE CART SHOULD BE FACING THE UNLOAD SIDE FOR PROPER UNLOADING AFTER A WASHING CYCLE. THE USER FACILITY COULD NOT CONFIRM THE POSITION OF THE CASE CART AT THE TIME OF THE REPORTED EVENT AND THEREFORE IT IS POSSIBLE THE EMPLOYEE COULD NOT SEE THE HANDLES TO ENSURE PROPER REMOVAL. THE EMPLOYEE WHO SUSTAINED THE INJURY WAS NEW TO THE DEPARTMENT. STERIS PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND HANDLING OF THE CASE CART AND WASHER. THE CASE CART SUBJECT OF THE REPORTED EVENT IS NOT SERVICED OR MAINTAINED BY STERIS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA MEDWATCH (B)(4) THAT EMPLOYEES ARE SUSTAINING HAND INJURIES WHEN REMOVING CARTS FROM THE CART WASHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463021 1227 CART WASHER WASHER FLH STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other