- Firm Announcement Date:
- FDA Publish Date:
- Product Kind:
- Medical Units
- Motive for Announcement:
Recall Motive Description
Potential for affected person oxygen desaturation (low blood oxygen) occasions that may happen underneath sure circumstances when the Life2000 system is related with a third-party oxygen concentrator
- Firm Title:
- Baxter Worldwide Inc.
- Model Title:
- Product Description:
Life2000 Air flow System
Baxter Worldwide Inc. introduced at this time it has issued an Pressing Medical Gadget Correction for the Life2000 Air flow System because of the potential for affected person oxygen desaturation (low blood oxygen) occasions that may happen underneath sure circumstances when the Life2000 system is related with a third-party oxygen concentrator. The Life2000 system is manufactured by Hillrom, which was acquired by Baxter in late 2021.
Low oxygen saturation could result in signs corresponding to shortness of breath, confusion, speedy coronary heart fee or bluish pores and skin. Among the many most susceptible sufferers, dying, life-threatening occasions or everlasting impairment could happen if sufferers or caregivers don’t acknowledge decrease oxygen ranges. Eventualities that might result in oxygen desaturation embrace hoses which can be kinked or have extreme moisture; modified, prolonged or free/disconnected tubing; oxygen liter move from the concentrator that has fallen under the prescribed degree whereas utilizing the Life2000 system; and/or non-compliance with advisable cleansing and upkeep of the Life2000 system and oxygen concentrator. Baxter has obtained reviews of affected person desaturation that required hospitalization. Primarily based on evaluation so far, no deaths have been reported associated to this subject.
As described within the Pressing Medical Gadget Correction issued on January 25, 2023, sufferers can proceed to make use of the Life2000 system in the event that they observe day by day checks and preventive upkeep necessities as detailed within the affected person letter and Directions for Use for each the Life2000 Air flow System and third-party oxygen concentrators. These actions will assist guarantee the very best oxygen supply with the Life2000 system when used with a third-party oxygen concentrator.
Baxter is constant to watch and examine reviews obtained and is presently investigating enchancment alternatives. Baxter will subject a follow-up letter to sufferers to speak additional particulars on the actions being taken to handle this subject.
This Pressing Medical Gadget Correction applies to all Life2000 Air flow Techniques used with an oxygen concentrator, together with the Life2000 Ventilator Packaged (BT-20-0002); the Life2000 Ventilator Packaged A (BT-20-0002A); the Life2000 System AC Bundle (BT200007); the Breathe Life2000 Ventilator PA (BT-20-0007); the Life2000 System HC Bundle (BT200011); the Breathe Expertise Life2000 VE (BT-20-0011); and the Life2000 Ventilator V6.X (MS-01-0118).
The Life2000 System is distributed in the US. Prospects with further questions can contact Baxter’s Medical Help Group at 800-397-9071. For components substitute, clients can contact Baxter Buyer Service at 800-426-4224, possibility 3 between the hours of seven:30 a.m. and 6 p.m. Central Time, Monday by means of Friday.
Any hostile occasions skilled with the usage of this product could also be reported utilizing one of many following choices:
- Calling Baxter Buyer Service at 800-426-4224, possibility 3, between the hours of seven:30 a.m. and 6 p.m. Central Time, Monday by means of Friday.
- Reporting to the FDA MedWatch Critical Harm Reporting Program:
Baxter is voluntarily issuing this Pressing Medical Gadget Correction and the U.S. Meals and Drug Administration has been notified of this motion.
Firm Contact Data
- Baxter’s Medical Help Group