On (b)(6) 2020 a preparation that was compounded by an i.V.Station device had a label affixed that contained incorrect content.The beyond use date (bud) printed on the label exceeded the expiration date provided by the vial manufacturer.Specifically, hydromorphone drug preparations were labeled with a bud of (b)(6) 2020 while the drug vial indicated an expiration date of (b)(6) 2020.The software, which is intended to consider vial expiration dates when calculating the bud, did not perform as intended and applied a date beyond allowable use.The mislabeled preparations were identified and there are no known adverse patient effects.
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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.Additionally, the contact office- manufacturing site at the time of this event was health robotics.Therefore, this report is a correction to the manufacturer listed in sections d3 and g1.
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