Devices

Fresenius Recalls Ivenix Pumps Over Software Issue

Fresenius Kabi has recalled (Class 1 device correction) its Ivenix Large Volume Pump due to a software issue. The recall applies to the Ivenix devices version 5.10.1 and earlier. Fresenius has instructed customers to update to software version 5.10.2 as soon as possible.

According to an FDA notice, the correction addresses two software anomalies that could interrupt infusion therapy. The first issue involves inaccurate battery capacity reporting when pumps operate for extended periods on battery power. Affected pumps may fail to deliver the standard low-battery alarm sequence — typically issued at 30, 15, 5, and 1 minute remaining — potentially leading to unexpected shutdown. Such shutdowns could interrupt ongoing infusions or prevent therapy from starting.

The second anomaly occurs when a clinician enters an infusion rate with two leading zeros (for example, “0010”) that exceeds drug library limits, FDA says. If the user presses “Back” or “OK” on the set rate screen, the pump may enter a fail-stop alarm state that freezes the interface. In such cases, therapy may be delayed or interrupted while the device is rebooted, replaced, or troubleshooting measures are taken.

The extent of potential harm depends on the patient’s condition, the medication being administered, and the time required to resolve the issue, the agency says.

The devices are used in hospitals and outpatient settings to deliver fluids, medications, blood products and other therapies through intravenous, intra-arterial, epidural and subcutaneous routes. It is indicated for adult, pediatric and neonatal patients.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome