BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I.V.STATION

    MDR report key: 5797661 · Received July 15, 2016

    Report

    Report Number
    3006153342-2016-00001
    Event Type
    Injury
    Date Received
    July 15, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 6, 2016
    Manufacturer
    HEALTH ROBOTICS S.R.L.
    Product Code
    NEP
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S INVESTIGATION DETERMINED THE ACTION PERFORMED BY THE PHARMACY TECHNICIAN CAN BE DESCRIBED AS A USER ERROR. THE DEVICE WAS OPERATING ACCORDING TO ITS SPECIFICATIONS WHEN THE PHARMACY TECHNICIAN INTRODUCED HER ARM INSIDE THE CAPPER DOOR TO ROTATE A VIAL THAT WAS LOCATED ON THE VIAL CRADLE, HOPING TO ACCELERATE THE PROCESS OF TURNING THE VIAL. ACCORDING TO THE DEVICE LOGS AND THE PHARMACY TECHNICIAN'S DESCRIPTION OF THE EVENTS, THE MANUFACTURER UNDERSTANDS THE SEQUENCE OF EVENTS AS FOLLOWS: THE VIAL WAS PLACED BY THE ROBOT ARM IN THE VIAL CRADLE FOR RECOGNITION; THE VIAL NEEDED TO BE TURNED BY THE DEVICE IN ORDER FOR THE LABEL TO BE RECOGNIZED; BEFORE THE ROBOT ARM STARTED THE ROTATION OF THE VIAL, THE PHARMACY TECHNICIAN INTRODUCED HER ARM INTO THE DEVICE WITH THE OBJECTIVE OF ROTATING THE VIAL AND ACCELERATING THE PROCESS; THE ROBOT ARM CONTINUED THE PROCESS OF TURNING THE VIAL, BUT ENCOUNTERED THE PHARMACY TECHNICIAN'S HAND AND CLIPPED IT CAUSING AN INJURY; AND THE DEVICE EMERGENCY STOP WAS ACTIVATED AND THE DEVICE STOPPED. THE PHARMACY TECHNICIAN ACKNOWLEDGED THAT THE ACTION SHE PERFORMED WAS WRONG.

    Description of Event or Problem · 1

    A PHARMACY TECHNICIAN SUFFERED A MINOR LACERATION TO HER LEFT HAND AFTER INTRODUCING HER ARM INTO THE OPERATING DEVICE IN AN ATTEMPT TO TURN A VIAL INSIDE OF THE DEVICE WHILE IT WAS RUNNING. THE PHARMACY TECHNICIAN WAS TREATED WITH STITCHES, RELEASED AND RESUMED WORK THE SAME AFTERNOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452248 I.V.STATION PHARMACY COMPOUNDING DEVICE NEP HEALTH ROBOTICS S.R.L. I.V.STATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention