MAUDE Adverse Event Report: OMNICELL, INC. OMNICELL I.V.STATION; PHARMACY COMPOUNDING DEVICE

Model Number	I.V. STATION
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020 an i.V.Station device passed three underdosed syringe preparations.The syringes contained approximately 4ml of neostigmine drug solution when they should have contained 5ml.No errors were generated and the incorrect volume issue was not able to be reproduced.A system modification was made to enable the robot pincer pressure regulator in order to ensure that the syringe is not handled with excessive pressure causing potential drug loss after the preparation has been weighed and marked acceptable.The preparations were visually identified and rejected and there are no known adverse patient effects.
Additional Manufacturer Narrative
As of january 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.

• Brand Name: OMNICELL I.V.STATION
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 10332184
• Report Number: 3011278888-2020-00013
• Device Sequence Number: 3623864
• Product Code: NEP
• UDI-Device Identifier: 08056477790007
• UDI-Public: (01)08056477790007(11)171108
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: I.V. STATION
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other