B. Braun Medical is voluntarily recalling one lot of an infusion pump administration set due to the potential for leakage and disconnection.
Customers complained about the problems occurring at the bonded joint between the tubing and injection site for the company’s Infusomat space volumetric infusion pump administration sets, according to the Melsungen, Germany-based company. The pumps deliver parenteral fluids.
Leakage or disconnection may leave the fluid path vulnerable to contamination by microorganisms that could cause a bloodstream infection, the company said. An open fluid path could also allow air to enter the circulatory system, which might lead to air embolization. B. Braun said it has received 17 complaints, none associated with patient death or serious injury.
The company is recalling 2,580 sets manufactured on September 21, 2018 and distributed between November 23, 2018, and March 20, 2019, and said it notified distributors and customers in an April 30 letter.
B. Braun identified the sets with catalog number 363032 and lot number 0061641410.