Infusomat Infusion Pump Recall Issued Over Leaks

Federal health officials have announced a recall for Infusomat infusion pump sets, after the manufacturer received more than a dozen reports of problems where the the devices leaked or disconnected at the joints, posing an increased risk of infection and injury.

The Infusomat Infusion Pump recall was announced by the U.S. Food and Drug Administration (FDA), after the manufacturer received at least 17 complaints of the bonded joints between the tubing and the injection site leaking or becoming disconnected while in use.

The recalled Infusomat pump systems are designed to deliver fluids, medications, blood and blood products to adults, children and newborns.

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According to the complaints, patients have encountered situations where the infusion pump administration set leaked or disconnected at the bonded joint between the tubing and injection site. In the event of a leak or disconnection, microorganisms could contaminate the fluids, entering the patient’s circulatory system and cause an increased risk of blood infection.

Officials have also warned that if the fluid path opens from a disconnection, there is potential for air to enter the circulatory system which could lead to air embolization, requiring emergency medical intervention.

The recall includes approximately 2,580 Infusomat Space Volumetric Infusion Pump Administration Sets marked with Catalog Number 363032 and Lot Number 0061641410. The devices were manufactured by B. Braun Medical Inc. of Bethlehem, Pennsylvania on September 21, 2018 and distributed to hospitals and medical centers in the United States and Canada from November 23, 2018 to March 20, 2019.

Customers are being asked to discontinue the use of the recalled infusion pumps immediately and to contact B. Braun Medical Inc. Customers Support Department at 1-800-227-2862 for instructions on how to return the affected administration sets for either a replacement product or refund.

Adverse reactions or quality problems experienced with the recalled devices should be reported to B. Braun Medical Information Department at 1-800-854-6851 or the FDA’s MedWatch Adverse Event Reporting Program.


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