BEUDAMED
    FDA Adverse Event Summary report: N

    RELIANCE TRANSFER CART

    MDR report key: 1973170 · Received January 28, 2011

    Report

    Report Number
    9680353-2011-00002
    Date Received
    January 28, 2011
    Date of Event
    November 29, 2010
    Report Date
    January 28, 2011
    Manufacturer
    STERIS CANADA CORPORATION
    Product Code
    LDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TRANSFER CART AND FOUND THE LATCH SPRING MECHANISM ON THE TRANSFER CART WAS NOT FUNCTIONING PROPERLY DUE TO THE SPRING BEING LOOSE, WHICH ALLOWED THE MANIFOLD RACK TO FALL ON THE OPERATOR'S WRIST WHEN SHE ATTEMPTED TO PULL THE CART BY GRABBING THE MANIFOLD RACK. THE TECHNICIAN REPLACED THE LATCH MECHANISM AND PLACED THE CART BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED WITH THE EQUIPMENT. THE TRANSFER CART IS NOT UNDER STERIS SERVICE CONTRACT AND IS CURRENTLY MAINTAINED AND SERVICED BY THE USER FACILITY. THE EQUIPMENT OPERATOR MANUAL STATES (PP.4-2): "ROUTINE MAINTENANCE - VERIFY THE LATCH IS IN GOOD CONDITION, TIGHTEN SCREWS IF NEEDED." IN ADDITION, THE OPERATOR MANUAL STATES( PP. 3-2): "SECURE BASKET ON CART WITH LATCH." THE INOPERABLE LATCH MECHANISM PREVENTED THIS STEP FROM BEING PROPERLY COMPLETED. STERIS WILL OFFER IN-SERVICE TRAINING ON THE PROPER EQUIPMENT MAINTENANCE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN AN OPERATOR INJURED HER HAND WHILE MOVING A LOADED TRANSFER CART TO LOAD IT INTO A WASHER. THE OPERATOR WAS MOVING THE TRANSFER CART BY PULLING THE MANIFOLD RACK LOADED ON THE CART AND THE MANIFOLD RACK STARTED TO COME OFF THE CART TOWARDS THE OPERATOR. THE OPERATOR USED HER RIGHT HAND TO PREVENT THE MANIFOLD RACK FROM FALLING ON HER UNTIL ANOTHER HOSPITAL EMPLOYEE WAS ABLE TO ASSIST HER. AFTER THE INCIDENT THE OPERATOR WENT TO THE OCCUPATIONAL HEALTH DEPARTMENT WHERE ICE AND A BANDAGE WERE APPLIED. SHE FOLLOWED UP WITH HER FAMILY PHYSICIAN WHERE SHE RECEIVED AN X-RAY WHICH SHOWED IRREGULAR RESULTS AND WAS ADVISED TO FOLLOW UP WITH A SPECIALIST. THE PHYSIOTHERAPIST SPECIALIST DIAGNOSED HER WITH TISSUE HARDENING IN HER RIGHT WRIST. THE OPERATOR RECEIVED ULTRASOUND SOFTENING AND IS CURRENTLY UNDERGOING PHYSIOTHERAPY FOR HER WRIST. SHE HAS RETURNED TO WORK ON LIGHT DUTY WITH A WRIST BRACE.

    Description of Event or Problem · 1

    STERIS HAS CONTACTED THE USER FACILITY SEVERAL TIMES TO OBTAIN THE EMPLOYEE'S CURRENT STATUS, HOWEVER NO INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE EMPLOYEE HAS RETURNED TO HER NORMAL WORK DUTIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANCE TRANSFER CART TRANSFER CART LDS STERIS CANADA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other