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 02/04/2020

Event Type  malfunction  

Event Description

On (b)(6) 2020 multiple spills involving chemotherapy drug preparations occurred inside the i.V.Station onco device.The spills were identified and subsequently cleaned by the user.The needle guidance pincers used in the bag injection process were not functioning correctly, were found to be dirty and were cleaned to restore proper functionality and prevent recurrence.There is no adverse patient effect related to these drug spills 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 16066
• MDR Report Key: 9758459
• MDR Text Key: 190361797
• Report Number: 3011278888-2020-00004
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• 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
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other