Baxter announces vent correction
By HME News Staff
Updated 9:20 AM CDT, Tue March 14, 2023
DEERFIELD, Ill. – Baxter International 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 may occur under certain conditions when the system is connected with a third-party oxygen concentrator. Low oxygen saturation may lead to symptoms like 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 lower oxygen levels are not recognized. 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 system; and/or non-compliance with recommended cleaning and maintenance of the system and oxygen concentrator. Baxter has received reports of patient desaturation that required hospitalization; however, based on analysis to date, no deaths have been reported related to this issue. As described in the Urgent Medical Device Correction issued on Jan. 25, 2023, patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements as detailed in the patient letter and Instructions for use for both the Life2000 Ventilation System and third-party oxygen concentrators. Baxter continues to monitor and investigate reports received and is currently investigating opportunities for improvement. It will issue a follow-up letter to patients to communicate further details on the actions being taken to address this issue. FMI: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-medical-device-correction-life2000-ventilation-system-due-potential-patient#recall-announcement.
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