This recall involves correcting certain 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
The FDA is aware that Fresenius Kabi has issued a letter to affected customers recommending all Large Volume Pump Software be corrected prior to continued use.
Affected devices:
- Ivenix Large Volume Pump Software
- Version: 5.10.1 and earlier
- Product Code: LVP-SW-0005
What to Do
Update software to version 5.10.2 as soon as possible. Review and become familiar with the temporary risk mitigation actions for each anomaly as described in the table below until the software is updated to version 5.10.2.
On November 14, Fresenius Kabi sent all affected customers a letter recommending the following actions:
- Review and become familiar with the temporary risk mitigation actions for each anomaly as described in the table below until the software is updated to version 5.10.2.
- If your facility further distributes and/or transfers products to satellite sites or other locations, notify any anticipated device users of this recall.
- To facilitate the installation of the pump software:
- First, install the new Ivenix Infusion Management System (IMS) software version 5.2.2 on your IMS server through the IMS Systems Administrator.
- Once the IMS software is updated, the LVP will automatically check for software version 5.10.2. Refer to the installation instructions below to complete the LVP update.
- After the IMS (5.2.2) and LVP (5.10.2) software versions are installed:
- Review the battery health of your organization's pump fleet using the Tip Sheet on How to Monitor Pump Battery Health.
- For pumps identified with a battery health of 70% or less, replace both batteries following the Ivenix LVP Battery Replacement Kit Instructions.
- NOTE: A battery health level of 70% or below can adversely affect performance, with further declines increasing vulnerability to functionality.
- Post the provided letter in areas where affected devices are stored and used ensuring users are aware of the issues and recommended risk mitigation measures.
List of Anomalies, Potential Risk and Temporary Risk Mitigations until Software Is Updated
The new software release (LVP Software Version 5.10.2) addresses the anomalies listed below.
The following table outlines each anomaly, its potential risks, and temporary risk mitigation measures that must be followed until the relevant software update is installed.
| Anomaly Description | Potential Risk | Healthcare Provider Temporary Risk Mitigation |
|---|---|---|
| Ivenix LVPs operating for extended periods on battery power may inaccurately report remaining capacity. This can result in unexpected shutdown without the standard low-battery alarm sequence (30-, 15-, 5-, and 1-minute remaining). Pumps with greater accumulated battery usage are more susceptible to this issue. | Inaccurate battery capacity indication can lead to unexpected battery depletion, causing therapy interruption or preventing infusion initiation. | Prior to updating to software version 5.10.2, keep the Ivenix LVP plugged in during use whenever possible. After the software update, review battery health in the Battery health Status Report to identify batteries that require replacement. |
| If a rate with two leading zeros (e.g., 0010) is entered on the LVP that exceeds drug library limits, pressing ‘Back’ or ‘OK’ on the Set Rate screen causes the pump to enter a fail-stop alarm state, freezing the LVP interface. | Delay or interruption of therapy if reprogramming stops an active infusion. |
Prior to updating to SW version 5.10.2, avoid programming an infusate with two leading zeros when possible. Fail-stop alarm states may require an LVP reboot, obtaining a new pump for temporary use, and/or administering an infusate to gravity during troubleshooting. |
How to Obtain and Install Software Version 5.10.2
To request installation, please reach out promptly to your Fresenius Kabi representative (1-855-354-6387 or Ivenix_support@fresenius-kabi.com). They will push the new software update to each of your pumps. When the LVP version 5.10.2 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 5.10.2 software update.
Note: the LVP will not be available for use during a software update.
Avoid selecting the 'Cancel' or 'Shut Down Pump' buttons on the prompt. Selecting either will prevent the software update, and the pump will continue to prompt for the update each time it is shut down until it is successfully initiated.
Reason for Correction
Fresenius Kabi stated that the affected software contains anomalies that could cause serious patient harm or death.
The two anomalies are:
- Ivenix LVPs operating for extended periods on battery power may inaccurately report remaining capacity. This can result in unexpected shutdown without the standard low-battery alarm sequence (30-, 15-, 5-, and 1-minute remaining). Pumps with greater accumulated battery usage are more susceptible to this issue.
- If a rate with two leading zeros (e.g., 0010) is entered on the LVP that exceeds drug library limits, pressing ‘Back’ or ‘OK’ on the Set Rate screen causes the pump to enter a fail-stop alarm state, freezing the LVP interface.
These issues may cause delays or interruptions to infusion. The extent of harm resulting from delayed or interrupted therapy depends on the time taken to identify and resolve the issue, the patient's underlying medical condition, and the criticality of the administered therapy.
As of November 18, Fresenius Kabi has reported two serious injuries and no deaths associated with this issue.
Device Use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration: intravenous, intra-arterial, epidural, and subcutaneous to adults, pediatric and neonate patients. Administered fluids may be pharmaceutical drugs, red blood cells, platelets, plasma, and other mixtures required for patient therapy.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Fresenius Kabi at Ivenix_support@fresenius-kabi.com or 1-855-354-6387.
Additional FDA Resources:
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.
