Baxter Warns of Potential Patient Oxygen Desaturation with Life2000 Ventilation System
Baxter International announced that it issued an urgent medical device correction for potential patient oxygen desaturation, or low blood oxygen, under certain conditions when its Life2000 ventilation system is connected to a third-party oxygen concentrator.
Low oxygen saturation can lead to shortness of breath, confusion, rapid heart rate or even death in vulnerable patients. The company has received reports of hospitalization from the problem but no deaths.
Baxter said it is still investigating possible scenarios leading to the oxygen desaturation including hoses that are kinked or have excessive moisture, loose or disconnected tubing, oxygen flow from the concentrator that has fallen below the prescribed level, or inadequate cleaning and maintenance.
The FDA posted a Mar. 10 update on Baxter’s urgent device correction issued Jan. 25, noting that the company plans to update patients with further details on the actions being taken to address the problem.