Baxter International has announced issuance of an Urgent Medical Device Correction through FDA for its Life2000 Ventilation System due to risk for patient oxygen desaturation. Potential oxygen desaturation events, according to Baxter, may occur under certain conditions when the system is connected with a third-party oxygen concentrator.
Life2000 is manufactured by Hillrom, which Baxter acquired in late 2021. The system is a noninvasive ventilator designed to provide breathing support.
The company released its initial Urgent Medical Device Correction on Jan. 25, 2023, and has stated that patients can continue using the system if they follow daily checks and preventative maintenance requirements as detailed in the patient letter and instructions of use for both the Life2000 and third-party oxygen concentrators. Continuing these actions will help ensure the system delivers optimal oxygen when used with a third-part oxygen concentrator.
FDA stated that the device correction applies to all Life2000 systems used with an oxygen concentrator:
- Life2000 Ventilator Packaged (BT-20-0002)
- Life2000 Ventilator Packaged A (BT-20-0002A)
- Life2000 System AC Package (BT200007)
- Breathe Life2000 Ventilator PA (BT-20-0007)
- Life2000 System HC Package (BT200011)
- Breathe Technology Life2000 VE (BT-20-0011)
- Life2000 Ventilator V6.X (MS-01-0118)
When low oxygen saturation occurs, it can lead to symptoms like shortness of breath, confusion, rapid heart rate, or bluish skin. Vulnerable patients that experience lower oxygen levels could be put into life-threatening situations, have permanent impairment, or die if caregivers do not recognize symptoms. Symptoms can result from kinked hoses, hoses with excessive moisture, modified, extended or loose/disconnected tubing, oxygen liter flow from the concentrator that has fallen below a prescribed level, or non-compliance with recommended cleaning and maintenance required of the system and oxygen concentrator.
Baxter revealed they have received reports of patient desaturation that required hospitalization, but no deaths related to the issue.
This is not the first time Baxter has been in the hotseat with their ventilators. Just last year, FDA announced a Class I recall of the company’s Volara ventilator system after receiving reports of two device-associated deaths. Of note, the Volara system was also brought to market by Hillrom.