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

Model Number	I.V. STATION ONCO
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020 two spills involving paclitaxel chemotherapy drug preparations occurred inside the i.V.Station onco device.The device identified the spills and notified the user who subsequently cleaned the spills.The cause of the spills was due to misalignment between the injection needle and bag port; when the drug doser rotated down the non-centered needle bent and punctured the wall of the port resulting in spillage.The shelf at the bag injection point was radially adjusted to prevent misalignment and recurrence of this issue.There is no adverse patient effect related to this drug spill within the device.
Additional Manufacturer Narrative
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.

• Brand Name: OMNICELL I.V.STATION ONCO
• Common Device Name: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 10711245
• Report Number: 3011278888-2020-00025
• Device Sequence Number: 3482832
• Product Code: NEP
• UDI-Device Identifier: 08056477790014
• UDI-Public: (01)08056477790014(11)161111
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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 ONCO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 05/25/2021
• 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