Devices

Alert on Misassembled Fresenius Infusion Pump Components

FDA has issued an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ivenix large volume pump (LVP) primary administration sets that could cause dangerous reverse fluid flow and delay critical medication delivery. The issue involves a misassembly in one lot of administration sets in which the drip chamber and luer lock are mistakenly reversed, the alert says.

According to FDA, the defect can cause the infusion system to draw fluid back from the patient and push it toward the source container instead of delivering therapy as intended. The misassembled sets also contain significantly shorter downstream tubing, which may hinder connection to the patient without additional extension tubing.

If used with the Ivenix LVP pump, the reversed configuration may result in unexpected infusate delivery or dangerous delays in life-saving fluids, blood products, or medications. Clinical risks range from minor blood loss in stable adults to catastrophic outcomes such as exsanguination or hemodynamic collapse in vulnerable patients, including neonates or those who are critically unstable, the alert says.

The Ivenix LVP is a large-volume infusion pump used to deliver medications and fluids from one or two source containers through a single outlet to 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