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 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

Upon inspection of the device, the service technician confirmed that the antileakage parameter needed to be adjusted.It was adjusted to meet the parameters of the configuration document.No additional information is available at this time.

Event Description

It was reported that between injecting doses, pacitaxel was spilled by the device.Specifically, the user ran 2 paclitaxel doses of 25ml (150mg) for a total of 50ml (300mg) and it drew up both doses using a 50ml syr.The issue came up after it injected the first dose.When the needle was pulled out of the bag it was dripping continuously until it put the needle into the second bag.No adverse events were reported as a result of this malfunction.

• Brand Name: OMNICELL I.V. STATION ONCO
• Type of Device: PHARMACY COMPOUNDING DEVICE
• Manufacturer (Section D): OMNICELL, INC; 51 pennwood place; warrendale PA 15086
• Manufacturer (Section G): OMNICELL, S.R.L; piazzale legnami 1/b edificio; 9 comprensorio gaslini; trieste, trieste 34145 ; IT 34145
• Manufacturer Contact: david vanella ; 500 cranberry woods drive; cranberry twp, PA 16066
• MDR Report Key: 11812428
• MDR Text Key: 250213935
• Report Number: 3011278888-2021-00006
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 08056477790014
• UDI-Public: (01)08056477790014(11)161111
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2021

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: 04/21/2021
• Initial Date FDA Received: 05/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1