On (b)(6) 2019 a spill involving a chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device, however, there is a concern regarding user exposure during clean-up of the spill.
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The event was originally filed under 3011278888-2019-00098 as follows: on (b)(6) 2019 a spill involving a chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device, however, there is a concern regarding user exposure during clean-up of the spill.The cause of the spill was not yet determined at the time of submission.Since then new information has determined that the spill was due solely to the use of non-configured consumables on the i.V.Station onco.Syringes from a different manufacturer that had not been configured or approved for use on the i.V.Station onco device were being loaded for the drug preparation process.These syringes exhibited different dimensions from the validated syringes.As a result, the syringe needle was not always able to puncture the second membrane of the i.V.Bag.Subsequently, the bag port would fail due to an overpressure of the port causing drug to spill into the device.Event problem and evaluation codes have been updated to reflect this new information.
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