UNITED STATES – Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for the Life2000 Ventilation System due to the potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions when the Life2000 system is connected with a third-party oxygen concentrator.
The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in late 2021.
Low oxygen saturation may lead to symptoms such as 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 patients or caregivers do not recognize lower oxygen levels. Scenarios that could lead to oxygen desaturation include hoses that are kinked or have excessive moisture; modified, extended or loose/disconnected tubing; oxygen liter flow from the concentrator that has fallen below the prescribed level while using the Life2000 system; and/or non-compliance with recommended cleaning and maintenance of the Life2000 system and oxygen concentrator. Baxter has received reports of patient desaturation that required hospitalization. Based on analysis to date, no deaths have been reported related to this issue.