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

Model Number	I.V. STATION ONCO
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection of the device by the technician, it was determined that the needle was completely bent.The injection position of the needle was not centered and the needle grippers were of the old style.The grippers were replaced and the needle was replaced and re-centered.The device was returned to operation.No additional information is available at this time.
Event or Problem Description
On (b)(3), the user attempted to prepare a toxol preparation and the robot missed the iv bag.This resulted in a taxol spill (~25ml) within the device.No adverse events were reported as a result of the malfunction.
Additional Manufacturer Narrative
As of (b)(6) 2020, the establishment registration and listing for the manufacturer of this device was updated to omnicell, inc.From aesynt, inc, which was not reflected in the original report submission.Additionally, as of (b)(6) 2021, the establishment registration and listing for the contact office of this device was updated from health robotics to omnicell s.R.L, which was not reflected in the original report submission.Therefore, this report is a correction to 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: 11551547
• Report Number: 3011278888-2021-00005
• Device Sequence Number: 17139958
• Product Code: NEP
• UDI-Device Identifier: 08056477790014
• UDI-Public: (01)08056477790014(11)161111
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 05/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1