Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
This recall involves correcting devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names: Ivenix Infusion System (IIS) LVP Software version 5.9.1 and earlier
- Unique Device Identifier (UDI)/Product Code: 00811505030122/ LVP‐SW‐0004
What to Do
- Update software to version 5.9.2.
On August 30, 2024, Fresenius Kabi USA, LLC, sent all affected customers an Urgent Medical Device Field Correction that included the following actions:
Required Actions for Users
- Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP).
- Until the new software is installed, follow the temporary risk mitigation steps outlined in the table:
| Description | Healthcare Provider Temporary Risk Mitigation Until Software 5.9.2 is installed |
|---|---|
| A software condition could result in the malfunction of the pneumatic valves, triggering a pump problem alarm. | Monitor the Ivenix LVP pump while completing any infusions prior to updating to software version 5.9.2 |
| A software condition could result in a malfunction of the system processor, that could cause the pump to trigger a pump problem alarm. | Monitor the Ivenix LVP pump while completing any infusions prior to updating to software version 5.9.2 |
| A condition could result in triggering a Tubing Set Problem alert/alarm, that could cause a pump problem alarm. | The issue may be resolved by power cycling the pump to continue any therapy in process and the delay would be limited to the time of power cycling. |
| If a pump repeatedly attempts to get an IP address from the server without success, it could result in the pump becoming nonfunctional. | The issue may be resolved by power cycling the pump to continue any therapy in process and the delay would be limited to the time of power cycling. |
| A software condition could result in the pump screen being unresponsive but continue with therapy. | The issue may be resolved by power cycling the pump to continue any therapy in process and the delay would be limited to the time of power cycling. |
| Cybersecurity vulnerability on the Large Volume Pump (LVP) that may allow a threat actor to access pump resources. | Evaluate the impact based on operational environment and specific clinical usage. Limit the number of individuals with “Can Provision Pumps” privileges to the infusion management system and follow best practices for system security. |
How To Obtain and Install Software Version 5.9.2
To request installation, please reach out promptly to the Fresenius Kabi representative (1-855-354-6387 or Ivenix_support@fresenius-kabi.com). They will push the new software update to the pumps.
When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down:
Select the Update Software button to initiate the LVP version 5.9.2 software update. Note that the LVP will not be available for use during a software update. Use care to not select the Cancel or Shut Down Pump buttons on the prompt as the software update will then not occur. The pump will prompt you every time you try to shut down the pump until the accept/ install update is selected.
Customer actions
- Fill out the customer reply form attached to acknowledge receipt.
- Ask locations where products were distributed or transferred to contact the email address on the customer reply form to allow for a direct notice to be sent.
Reason for Correction
Fresenius Kabi USA, LLC, is correcting the Ivenix Infusion System Large Volume Pump (LVP) software, an infusion pump software due to multiple software anomalies and a cybersecurity vulnerability that have the potential to result in delay or underdosage of therapy.
The use of affected product may cause serious adverse health consequences, including temporary irregular heartbeat (arrhythmia), hyperglycemia, low or high blood pressure (hypotension or hypertension), a lack of sedation (undersedation), blood clotting changes and death.
There have been no reported injuries and no reports of death.
Device Use
The Ivenix Infusion System is used in hospital and in outpatient care environments for the controlled administration of fluids to patients through accepted methods such as intravenous line (IVs), arterial lines, epidurals, and subcutaneous (under the skin) delivery. These fluids include medications, blood products such as red cells or plasma, or other agents needed for treatment of adult and pediatric patients, including neonates and infants.
Contact Information
Customers in the U.S. with questions about this recall should contact Fresenius Kabi USA, LLC, at ivenix_support@fresenius-kabi.com or call 1-855-354-6387.
Additional FDA Resources
- Related FDA recall classification summary: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death [04/17/2024]
- FDA's Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
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- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.