Iv robot - smartfiller from cargin, llc in operation since 2018 fills iv syringes for patient use.Over the course of 4 years, the robot has created many near-miss situations that could potentially compromise patient safety.The device has the potential to under fill syringes, package and label syringes without any medications added.Has happened on multiple occasions.Other issues include syringes labeled with incorrect barcode, incorrect beyond use dates, and drug name all errors which have been caught prior to patient distribution.Vendor has been uncooperative with resolution.Cargin llc, (b)(4) us.Fda safety report id # (b)(4).
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