BEUDAMED
    FDA Adverse Event Summary report: N

    60" CENTURY TRANSFER CART

    MDR report key: 1720013 · Received June 11, 2010

    Report

    Report Number
    3005899764-2010-00012
    Date Received
    June 11, 2010
    Date of Event
    May 13, 2010
    Report Date
    June 11, 2010
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY DECLINED STERIS' OFFER OF IN-SERVICE TRAINING.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN WENT ON-SITE TO INSPECT THE TRANSFER CART, HOWEVER WHEN HE ARRIVED, HE FOUND THAT THE FACILITY PERSONNEL HAD ALREADY RE-INSERTED THE WHEEL INTO THE CART LEG. UPON INSPECTION OF THE CART, THE TECHNICIAN FOUND THAT THE WHEEL HAD NOT BEEN PROPERLY RE-INSERTED. THE TECHNICIAN RE-INSERTED THE WHEEL CORRECTLY, TIGHTENED THE CASTER AND VERIFIED THAT ALL OTHER CASTERS WERE PROPERLY SECURED. THE CART WAS RETURNED TO SERVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED WITH THIS EQUIPMENT. THE STERIS SERVICE TECHNICIAN HAS OBSERVED IN THE PAST THE USER FACILITY PERSONNEL INCORRECTLY REMOVING THE TRANSFER CART FROM THE STERILIZER. SPECIFICALLY, EMPLOYEES WERE INSTRUCTED TO UNLOAD THE CART BY PULLING THE CART STRAIGHT OUT OF THE STERILIZER AND ARE NOT TO PULL OR PUSH ON THE SIDES OF THE CART TO REMOVE. STERIS HAS DETERMINED THE INCIDENT OCCURRED DUE TO USER ERROR AND HAS REINFORCED THE IMPORTANCE OF PULLING THE CART STRAIGHT OUT OF THE STERILIZER AND RECOMMENDED A VISUAL CHECK OF ALIGNMENT PRIOR TO PLACING OR REMOVING A CART FROM THE STERILIZER. STERIS HAS OFFERED THE FACILITY FORMAL REFRESHER IN-SERVICE TRAINING ADDRESSING THE PROPER LOADING AND UNLOADING PROCESS FOR TRANSFER CARTS AND ARE AWAITING THE USER FACILITY'S RESPONSE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHEN AN EMPLOYEE WAS LOADING A STERILIZER THE RIGHT REAR WHEEL OF THE TRANSFER CART CAME OFF, CAUSING THE CART RACK TO FALL TO THE FLOOR WHILE THE EMPLOYEE WAS HOLDING THE HANDLE OF THE LOADING CART RACK. THE EMPLOYEE WENT TO THE FACILITY EMERGENCY ROOM AND WAS GIVEN MEDICATION FOR PAIN. THE FACILITY REPORTED THE EMPLOYEE MISSED NO TIME FROM WORK AND SUSTAINED NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60" CENTURY TRANSFER CART TRANSFER CARRIAGE FLE STERIS MEXICO, S. DE R.L. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other