Patient oxygen desaturation (low blood oxygen) events can occur under certain conditions. These may happen when the Life2000 system connects with a third-party oxygen concentrator.
Hillrom — acquired by Baxter for $12.5 billion in 2021 — manufactures the Life200 system.
According to an FDA notice, low oxygen saturation may lead to symptoms including shortness of breath, confusion, rapid heart rate or bluish skin. Among the most vulnerable patients, death, life-threatening events or permanent impairment may occur if caregivers don’t recognize lower oxygen levels.
Scenarios that may lead to this issue include kinked hoses or hoses with excessive moisture. Additional scenarios include extended or loose/disconnected tubing, oxygen liter flow from the concentrator that falls below the prescribed level and/or non-compliance with recommended cleaning and maintenance.
Baxter received reports of patient desaturation that required hospitalization. Based on analysis to date, Baxter said it received no reports of death related to the issue.
The company issued an urgent medical device correction on Jan. 25, 2023. Patients may continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements.
Baxter said it continues to monitor and investigate reports received and improvement opportunities. The device correction applies to all Life2000 ventilation systems used with an oxygen concentrator.
The Life2000 System is distributed in the United States.
