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# Baxter Device Correction for Life2000 Ventilator
- URL: https://www.fdaweb.com/baxter-device-correction-for-life2000-ventilator/
- Published: 2023-03-10T12:00:00.000Z
- Updated: 2026-09-14T18:18:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153957

Baxter International says it has issued an “urgent medical device correction” for its Life2000 Ventilation System due to the “potential for patient oxygen desaturation (low blood oxygen) events that can occur under certain conditions” when the device is connected to a third-party oxygen concentrator.” The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in 2021.

The [company says](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-life2000-ventilation-system-due-potential-patient?ref=fdaweb.com) that low oxygen saturation may lead to 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,” it says. “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 says its correction notice tells customers that patients can continue to use the device if they follow daily checks and preventive maintenance requirements as detailed in a patient letter and Instructions for Use for both the Life2000 Ventilation System and third-party oxygen concentrators. It says it is monitoring reports received and “currently investigating improvement opportunities.”