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)

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

Event Date 01/25/2021

Event Type  malfunction  

Manufacturer Narrative

Due to the ongoing covid-19 pandemic, the customer has not provided access to the device to be evaluated by the manufacturer.Historical records indicate that this device has malfunctioned similarly in the past, but a singular root cause cannot be assigned.Should additional information become available, a supplemental report may be filed.

Event Description

It was reported that on date (b)(6), the onco station had a spillage during mixing of drug paclitaxel.No patient or user impact was reported.

Manufacturer Narrative

Repair technician reviewed the device and checked the needle insertion and drug parameters and found no issues that could have contributed to the alleged failure.The device was further reviewed and determined that the needle and pincher were relatively old, and therefore need to be replaced.The parts were ordered for the repair.No additional information is available.

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: 11337085
• MDR Text Key: 243920581
• Report Number: 3011278888-2021-00002
• 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,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• 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
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1