Dive Brief:
- Baxter International issued an urgent medical device correction notice for its Life2000 Ventilation System because users could experience low blood oxygen under certain conditions when the device is connected to a third-party concentrator, the U.S. Food and Drug Administration said Friday.
- Baxter has received reports of oxygen desaturation that required hospitalization, the FDA said. No deaths related to the issue were reported.
- The Life2000 system is manufactured by Hillrom, which Baxter acquired for $10.5 billion in late 2021.
Dive Insight:
Low oxygen saturation may lead to symptoms including shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death or permanent impairment are possible if patients or caregivers do not recognize lower oxygen levels, the FDA said.
Oxygen desaturation could occur if hoses become kinked, have excessive moisture or have been modified, or if tubing becomes loose or disconnected. Users could also be at risk when the oxygen liter flow from the concentrator has fallen below the prescribed level while using the Life2000 system, or when they fail to comply with recommended cleaning and maintenance of the system.
Patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements in the patient letter and instructions for both the Life2000 Ventilation System and third-party oxygen concentrators, Baxter said in its announcement posted by FDA.
Baxter said it is monitoring reports and investigating ways to address the problem, and will issue a follow-up letter to give patients further details on actions being taken.
Last year, the FDA categorized a recall of Baxter’s Volara ventilator system as a Class I event after receiving reports of two deaths associated with the device. Those systems also were brought to market by Hillrom.
