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Model Number I.V. STATION |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/11/2020 |
Event Type
malfunction
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Event Description
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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, syringe drug preparations were labeled with a bud of (b)(6) 2020 while the succinylcholine drug vial used in the preparation indicated an expiration date of october 1, 2020.The software, which should 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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Manufacturer Narrative
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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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Search Alerts/Recalls
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