FDA announces recall on infusion systems after software anomaly injures 2 patients
The U.S. Food and Drug Administration (FDA) is spreading awareness of an issue with a line of infusion pumps manufactured by Fresenius Kabi, after the company sent a letter to customers alerting them to multiple anomalies in the devices’ software that could pose a serious threat to patient health.
The pumps in question are Ivenix Large Volume Pumps (LVPs), used in hospital and outpatient care settings to automatically administer fluids, drugs, or blood products that are necessary to sustain the life of a patient.
Errors in the software can cause serious malfunctions that make the pumps too risky to use until a software update has been downloaded and installed. The two primary issues with the device are:
- Inaccurate battery capacity reading - If the LVPs are operating on battery power, they may give inaccurate readings about the current available charge. This has been known to lead to unexpected shutdowns, without the usual benefit of a warning alarm.
The FDA said this is known to happen more frequently on pumps that have been frequently used on battery power alone, without being plugged into an external power source.
- User lockout - If an incorrect infusion rate beginning with two leading zeros (e.g., 0010) is entered on the LVP, pressing the “back” or “OK” button will cause the pump to enter a fail-stop state, effectively freezing the interface.
In either case, this can result in the pumps failing in the middle of fluid delivery or drug treatments. Infusions may be further delayed by the additional time it takes to identify and remedy the shutdowns.
In critical situations—such as when blood or fluids are being administered during an emergency—this could seriously harm or kill a patient. To date, the FDA confirmed that two serious injuries have been reported.
Due to the serious risks associated with this software error, this recall has been designated as a Class I recall, the FDA’s most serious type. Impacted LVPs must be identified and corrective software installed immediately.
What is being recalled?
- Product Name: Ivenix Large Volume Pump
- Defective Software Version: 5.10.1 and earlier
- Product Code: LVP-SW-0005
See the above image for help identifying the recalled devices.
Next steps
The number one priority is to identify the LVPs and update the software on control units to version 5.10.2 as soon as possible. That’s the only way to ensure the pumps are safe to use.
To do that, users are advised to reach out to their Fresenius Kabi representative. Alternatively, the company can be reached at 1-855-354-6387 or [email protected]. As the devices are internet-connected, the new software can be pushed to the pumps remotely on request.
After the software—version 5.10.2—has been downloaded, a prompt will appear asking the user to install the update, shutting down the infusion systems until the process is complete. The FDA said users should avoid hitting “Cancel” or “Shut Down Pump” as it will prevent the update, resulting in the update prompt reappearing immediately upon reboot.
If there is some type of emergency situation where the infusion pump must be used but there is no time to update the onboard software, instructions were included in the FDA notice that would render the LVPs temporarily safe to use.
For more, read the full notice by clicking here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.