Fresenius Kabi Recalls Infusion Pump Over Leak Concerns

Fresenius Kabi is recalling upwards of 1,500 infusion pumps less than a year after spending $240 million to purchase Ivenix and their sensor- and software-backed infusion pump. 

According to a notification that was released by the FDA, the sole version of the large-volume pump that is included in the recall is the LVP-0004. At the end of October 2021 and the beginning of the current year, the systems were only deployed in a select few states in the U.S. and nowhere else abroad.

The notice states that the recall was formally initiated by Fresenius Kabi on March 8, but it wasn’t until this week that the FDA assigned a Class I classification to the event. This grade indicates that there is an increased risk of harm or death related to the issue.

Infusion pumps are utilized in the process of administering blood, medicines, and other fluids to patients through an intravenous line over a certain amount of time.

According to the company that developed the Ivenix infusion system, which received clearance from the FDA in 2019, the device is intended to be “smarter” than a conventional infusion pump. The pump itself has a user-friendly touchscreen as well as real-time guidance capabilities that instantly compare preset dosages to those that are indicated in the integrated medication library.

How the Infusion Pump Works

• The infusion pump is connected to the software that interacts with the electronic health record system used by the hospital.
• Dosing information is automatically entered into patients’ medical files by the pump once the connection has been established.
• With a computer or tablet outfitted with Ivenix’s proprietary dashboard software, clinicians have the ability to monitor all of the infusion data pertaining to their patients.
• The software can also track how the infusion pumps are being used.

According to the FDA, Fresenius Kabi initiated the recall after finding that a leak in the mechanism might allow fluids to seep into the administration set, which links the pump to the patient. If this does occur, the leak might cause harm to the internal electrical system of the pump, which would result in the pump losing power. This could prevent patients from receiving the fluids they require.

Fresenius Kabi has received a total of 14 complaints in relation to the issue; however, none of these complaints involve any evidence of a patient being injured or dying.

Fresenius Kabi said that it will soon begin communicating with the customers of the 1,546 impacted infusion systems to organize repairs of the systems, or complete replacements if repairs are not feasible. 

Meanwhile, medical professionals can continue to use the systems; however, the company has suggested that they keep a backup large-volume infusion pump on standby, particularly in circumstances in which the system is being used to administer fluids that are necessary for life support. If the Ivenix model fails to start or continue fluid delivery, they should change to an alternate pump and pay particular attention to any warnings or alerts that are generated by the systems.

The company said that clinicians must conduct routine checks of the administering set loading area of the pumps to look for signs of fluid accumulation. They should also promptly clean up any spills that occur there as well as any surplus liquid that is left over after a pump has been cleaned.

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