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

Model Number I.V. STATION ONCO

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 a spill involving a chemotherapy drug preparation occurred inside the i.V.Station onco device.The spill occurred during vial withdrawal or injection into the bag and may be attributed to consumables.The issue was not able to be reproduced.No device modifications were made and the issue has not recurred.The spill was identified and subsequently cleaned by the user.There is no adverse patient effect related to this drug spill within the device.

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
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC.; 51 pennwood place; warrendale PA 15086
• MDR Report Key: 10332186
• MDR Text Key: 201702085
• Report Number: 3011278888-2020-00014
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: I.V. STATION ONCO
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/10/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 05/07/2021
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other