Life2000 Ventilation System recall: reason, affected products, and all you need to know

Baxter International Inc. has announced an Urgent Medical Device Correction for their Life2000 Ventilation System over concerns about potential oxygen desaturation (low blood oxygen) events. The risks related to the alert could range from patients being hospitalized to them facing permanent impairment or even death. A recall for similar medical devices was issued in November 2020 but was later terminated on November 10, 2022.

Announced on March 10, 2023, the Urgent Medical Device Correction was issued following several reports of patient desaturation requiring hospitalization. As per the company's analysis, no deaths or severe fatalities have been reported in regards to the use of the concerned ventilation system.

The Life2000 Ventilation System can be used by connecting it to an oxygen concentrator. However, the currently reported cases have proven that when the ventilation system is used under certain conditions, it can lead to patient oxygen desaturation events. Baxter International Inc. said that such scenarios could have resulted from human error and/or the lack of proper cleaning and maintenance of the ventilation system and/or the oxygen concentrator.

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Patients can continue to use the Life2000 Ventilation System with caution

The Life2000 ventilation system, which is part of the Urgent Medical Device Correction, was manufactured by Hillrom, the company which Baxter acquired in late 2021. The ventilation system was distributed through medical retail channels to customers all across the United States. Moreover, it could already be in use by multiple patients nationwide.

The Urgent Medical Device Correction issued by Baxter International Inc. suggests that patients can continue to use the ventilation system if they maintain due caution. They further stated that patients and their caregivers should follow all daily checks and preventive maintenance in accordance with the 'Patient Letters and Instructions' that come with the Life2000 Ventilation System and third-party oxygen concentrators. Following these actions can help ensure the efficient delivery of oxygen while the ventilation system is being used with a third-party oxygen concentrator.

The affected ventilation systems were produced by Hillrom, a company that Baxter acquired in 2021 (Image via Baxter)

The Urgent Medical Device Correction, announced on March 10, 2023, affects all Life2000 Ventilation Systems that can be used with an oxygen concentrator. A list of the affected ventilation systems includes:

• Life2000 Ventilator Packaged (BT-20-0002)
• the Life2000 Ventilator Packaged A (BT-20-0002A)
• the Life2000 System AC Package (BT200007)
• the Breathe Life2000 Ventilator PA (BT-20-0007)
• the Life2000 System HC Package (BT200011)
• the Breathe Technology Life2000 VE (BT-20-0011)
• the Life2000 Ventilator V6.X (MS-01-0118)

As of now, Baxter is continuously monitoring the reports received from customers across the country. Though investigations into improvement opportunities are underway, the company is expected to communicate the next actions to address the issue shortly.

However, customers with doubts and queries about the Life2000 Ventilation System can contact Baxter’s Clinical Support Team at 800-397-9071. Consumers with queries about parts replacement can forward them to Baxter Customer Service at 800-426-4224, option 3. Both contact numbers can be reached between Monday to Friday, from 7.30 am to 6 pm Central Time (CT).