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

Model Number I.V. STATION ONCO

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/05/2021

Event Type  malfunction  

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 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.

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
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 11551547
• MDR Text Key: 243555415
• Report Number: 3011278888-2021-00005
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790014
• UDI-Public: (01)08056477790014(11)161111
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: I.V. STATION ONCO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1