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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/21/2021

Event Type  malfunction  

Event Description

On (b)(6) 2021 it was reported that in the morning the pharmacy reported a spillage issue with the drug behind the scale.The cause of the spill was due to misalignment between the injection needle and bag port; the drug doser did not rotate before to inject the drug into the bag.The software was updated to the new version, (b)(4), to correct the issue and prevent recurrence.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 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: 11267013
• MDR Text Key: 233487755
• Report Number: 3011278888-2021-00001
• 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: company representative,foreig
• 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?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/02/2021
• 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