Ivenix Infusion Pump Recall Issued Due to Risk of Severe Injury or Death

Manufacturer is instructing customers to stop using recalled Ivenix infusion pumps until new software is installed, to avoid serious risks that may be caused by the devices delivering reduced doses of medications and fluids.

An urgent medical device notification has been issued concerning problems with Ivenix Infusion System pumps, which could delay or reduce patient medications and fluids, posing a risk of serious and potentially life-threatening injuries.

The U.S. Food and Drug Administration (FDA) announced the Fresenius Kabi Ivenix Infusion System recall on October 1, warning healthcare professionals to stop using the recalled models until new software is installed.

The Ivenix Infusion System large volume pumps (LVP) are used in hospitals and outpatient centers to control the delivery of fluids like medications, blood products or other agents through intravenous lines (IVs), arterial lines, epidurals and under the skin. It is used for patients of all ages, from infants to adults.

The manufacturer has issued a correction for the device due to software issues and a cybersecurity risk, which could delay or reduce fluid delivery. This may lead to serious health problems like irregular heartbeat, high or low blood sugar, blood pressure issues, inadequate sedation, blood clots and even death.

While no injuries or deaths have been reported in connection with the recalled infusion pumps, the FDA classifies this action as a Class I recall, which is the most serious type, indicating that continued use of the product could cause serious injury or death.

Fresenius Kabi first alerted healthcare providers about a software defect in the Ivenix Infusion System through an Urgent Medical Device Field Correction letter on August 30. The letter advised customers to stop using the product immediately and provided the following temporary safety measures until new software is installed:

• If the pump problem alarm is triggered by a malfunction of the pneumatic valve or system processor triggers, the device should be monitored while finishing any infusions.
• If a Tubing Set Problem or pump alarm goes off, or if the pump screen freezes while fluids are being administered, users can do a hard restart on the pump. This will let the therapy continue with only a brief delay during the restart.
• If the pump cannot connect to the server and stops working, a hard restart can also fix this issue.
• A cybersecurity vulnerability with the pump could let someone access its resources. To fix this, assess how that would affect your clinic’s uses of the pump, limit who can access the “Can Provision Pump” feature, and follow best security practices for the system.

The recall involves pumps with Ivenix Infusion System (IIS) LVP Software version 5.9.1 and earlier, and Unique Device Identifier (UDI) / Product Code: 00811505030122 / LVP‐SW‐0004.

To obtain the new software, contact a Fresenius Kabi representative at 1-855-354-6387 or Ivenix_support@fresenius-kabi.com. Once the update is sent, the pump will show a prompt saying, “New software is available to update on pump.” The device cannot be used while updating.

Customers should complete the reply form attached to the recall notice and inform any locations where the products were sent to contact the email on the form so they can receive a direct notice.

Individuals in the U.S. can report any adverse reactions or quality problems they experience with these devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.