On (b)(6) 2020 a spill involving the chemotherapy drug preparation endoxan occurred inside the i.V.Station onco device.The spill, which was created as a result of misalignment between the syringe and injection point during dosing, was identified and subsequently cleaned by the user.Adjustments were made to the robot point for syringe insertion to prevent recurrence.There is no adverse patient effect related to this drug spill within the device.
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As of (b)(6) 2020, the establishment registration and listing for this device was updated to omnicell, inc.From aesynt, inc, which was not reflected in the original report submission.Therefore, this report is a correction to the manufacturer listed in sections d3 and g1.
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