On (b)(6) 2020 a spill involving the chemotherapy drug preparation paclitaxel occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.The drug was seeping from the loading syringe causing drips to accumulate on the bag clamps.Modifications were made to drug and syringe pressure, volume, speed and time parameters to prevent recurrence of the dripping.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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