Fresenius Kabi has issued a software correction notice for its Ivenix large-volume infusion pump following identification of a battery-display anomaly that may communicate inaccurate battery-health information to clinical staff. The U.S. Food and Drug Administration (FDA) has classified this as a device correction requiring immediate action by healthcare facilities.
Key takeaways
- Ivenix infusion pump software may display false battery-health values, potentially misleading clinical teams
- Fresenius Kabi recommends pumps remain continuously plugged into mains power as an interim safety measure
- Healthcare facilities should contact the manufacturer for software updates and implementation guidance
What went wrong: The battery-display anomaly
According to the FDA’s device correction alert, the Ivenix pump’s software contains an error that causes the device to report inaccurate battery-health status on its display interface. This anomaly does not affect the pump’s ability to deliver medication, but it may cause clinical staff to receive misleading information about the device’s power state—a critical safety consideration in hospital environments where backup power supplies are essential.
The correction addresses a software-level issue rather than a hardware failure, meaning the problem can be resolved through a firmware update distributed by Fresenius Kabi to healthcare facilities.
Infusion Pump Safety: Key Risk Categories
Battery-display errors rank among multiple device safety considerations requiring facility protocols
Source: FDA Medical Device Safety Framework | Georgian Medical Journal News
Interim safety recommendations: Continuous mains power requirement
Until the software update is installed and verified, Fresenius Kabi’s interim guidance—endorsed by the FDA—requires that all Ivenix pumps remain continuously connected to mains electrical power in clinical settings. This measure ensures uninterrupted pump function independent of the faulty battery-status display, reducing the risk of unexpected power loss during patient care.
Healthcare facilities using the Ivenix pump should contact Fresenius Kabi directly to obtain the corrected software and to schedule installation with trained biomedical technicians. The manufacturer has committed to providing clear implementation protocols and staff training materials.
Ivenix infusion pumps display inaccurate battery-health values due to a software anomaly; pumps must remain plugged into mains power until a corrective firmware update is installed.
— U.S. Food and Drug Administration (FDA) Device Correction Alert, 2026
Implementation pathway for healthcare facilities
Hospital pharmacy, clinical engineering, and nursing leadership should establish a coordinated response plan for Ivenix pump correction deployment. This includes: (1) verification of all affected pump serial numbers and locations within the facility; (2) prioritized scheduling of software updates during low-demand clinical periods to minimize workflow disruption; and (3) staff education on the interim mains-power requirement to prevent operational confusion.
The quality and patient safety protocols outlined by accreditation bodies such as The Joint Commission recommend documented verification that all pumps have been successfully updated and that staff competency with the corrected software has been confirmed prior to resuming normal operational protocols.
What this means
Frequently asked questions
Does this battery-display error affect medication delivery?
No. The Ivenix pump’s core medication-delivery system is unaffected by this software anomaly. Only the battery-health display on the pump’s interface is providing inaccurate information. Medication dosing and infusion accuracy remain normal.
What should we do if our facility uses Ivenix pumps?
Contact Fresenius Kabi immediately to verify if your specific pump serial numbers are affected and to schedule a software update with trained technicians. Until the update is installed, keep all Ivenix pumps continuously plugged into mains power. See the clinical updates section for guidance on device correction deployment.
How long does the software update take, and will it disrupt patient care?
The duration of the software installation depends on the facility’s pump inventory and technician availability. Fresenius Kabi works with healthcare facilities to schedule updates during low-demand periods to minimize workflow disruption. Your biomedical team should coordinate the timeline with the manufacturer.
As infusion pump technology becomes increasingly integrated with digital systems in hospital care, the ability to rapidly identify, communicate, and correct software-related safety issues will remain essential. Healthcare facilities and device manufacturers must continue strengthening partnerships to ensure that device corrections are implemented swiftly and comprehensively, protecting both patient safety and clinical staff confidence in medical device reliability.
Source: Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
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