The company’s decision comes as a result of the potential for patient oxygen desaturation (low blood oxygen) events, which can take place in certain conditions when the Life2000 system is linked with a third-party oxygen concentrator.
The Life2000 system is manufactured by Hillrom, which was taken over by Baxter in 2021.
The latest correction is said to be applicable to all Life2000 Ventilation Systems that are used with an oxygen concentrator, including the Life2000 Ventilator Packaged (BT-20-0002), Life2000 Ventilator Packaged A (BT-20-0002A) and Life2000 System AC Package (BT200007).
Other systems that come under the correction are the Breathe Life2000 Ventilator PA (BT-20-0007), Life2000 System HC Package (BT200011), Breathe Technology Life2000 VE (BT-20-0011) and Life2000 Ventilator V6.X (MS-01-0118).
Patients can continue to use the Life2000 system if they follow daily checks and preventive maintenance requirements according to an urgent medical device correction issued in January.
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These measures will help the system deliver better oxygen when it is used with a third-party oxygen concentrator, according to the FDA.
Baxter is continuing to monitor and evaluate reports received as well as study improvement opportunities.
The company will also issue a follow-up letter to patients to communicate further details on the actions that are being taken to address the issue.
Baxter currently supplies the Life2000 system in the US.
Low oxygen saturation can result in symptoms such as shortness of breath, confusion, rapid heart rate and bluish skin.
Oxygen desaturation incidents can be caused by hoses that are kinked or have excessive moisture; modified, extended, loose or disconnected tubing; and oxygen litre flow below the prescribed level from the concentrator.