Infusomat (infusion pumps)

2023: Pump recall after patient's death

On November 17, 2023, the US Food and Drug Administration (FDA) announced that the medical and pharmaceutical company B. Braun Medical is recalling defective infusion pumps of the Infusomat Space family. The use of these devices can cause serious harm to the health of patients and provoke a fatal outcome.

We are talking about wired and wireless devices Infusomat Space Large Volume Pump, which can be used in therapy in adults, children and newborns. The pumps are intended for administration of medicinal products and other fluids into the body.

Infusomat Space Pump

The problem is that on some Infusomat Space models, a false occlusion alarm can be triggered in the actual absence of a blockage. As a result, the device stops the supply of drugs, which is fraught with negative consequences - especially when high-risk drugs such as vasopressors are used. Unexpected stopping of therapy can lead to hemodynamic instability, requiring medical intervention to prevent irreversible impairment of body functions.

As of mid-November 2023, there were more than 50 complaints about defective B. Braun infusion pumps. One case of harm to health and one death were recorded. Devices supplied from October 26, 2022 to July 17, 2023 are subject to recall. In total, 10,655 defective devices were shipped to the market. The manufacturer will contact customers and send technicians to replace the occlusion pressure sensors. Until the problem is resolved, medical institutions are advised to use Infusomat Space pumps only for the delivery of low-risk drugs. In this case, the availability of an alternative pump for the administration of high-risk drugs should be ensured.^[1]

2019: B. Braun recalls defective infusion pumps

At the end of September 2019, B. Braun voluntarily recalls one of the batches of defective infusion pumps. It is assumed that the detected defects can lead to leakage of the drug and disconnection of the pump. Violation of the tightness of the infusion kit threatens not only the loss of the drug, but also infection of the blood flow.

The company received several complaints from customers who noted problems when using Infusomat infusion pumps. Due to a manufacturing defect, a disconnection of the catheter inserted into the vein and the volumetric infusion pump trunk was noted. Infusion pumps are used for parenteral fluid administration, and disruption of the system tightness can lead to catastrophic consequences, primarily the penetration of microorganisms into the bloodstream and to sepsis. In addition, violation of the tightness of the infusion set line can lead to air bubbles entering the circulatory system with the development of air embolism.

B. Braun voluntarily recalls one of the batches of defective infusion pumps

B. Braun said it had received 17 complaints. None of them were associated with the death of the patient or the development of serious injuries. The company investigated and found that all defective sets have catalog number 363032 and belong to batch 0061641410. Therefore, B. Braun is now recalling 2,580 infusion pumps released on September 21, 2018 and sold out between November 23, 2018 and March 20, 2019. The company reported possible malfunctions to all distributors and customers in a separate letter. Users are advised to stop using the device immediately and report it to B. Braun as soon as possible. If any adverse reactions or unforeseen effects occur, patients should contact their healthcare provider or pharmacist.^[2]

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