Baxter Healthcare has issued a correction for the Life2000 ventilator due to a potential alarm failure, with a software update forthcoming to address the issue.

RT’s Three K​ey Takeaways:

  1. Alarm Failure Risk Identified: Baxter Healthcare is updating use instructions for the Life2000 ventilator after identifying a potential failure in issuing low gas pressure alarms, which poses health risks, including desaturation and shortness of breath.
  2. Software Update Pending: A software update is in development to resolve the issue, and Baxter will notify all impacted customers once the update is available.
  3. Class 1 Recall Issued: The FDA has classified this as a Class 1 recall, the most serious type.

Baxter Healthcare is updating use instructions for the Life2000 ventilator after identifying that this ventilator may fail to issue a low gas pressure alarm if the pressure gas source (Life2000 compressor, oxygen cylinder, or wall source) is not connected to the ventilator and turned on before starting therapy. 

According to a notice from the US Food and Drug Administration (FDA), the firm is currently working on a software update to address this issue and will contact all impacted customers to update their devices once the update is available. 

The use of the affected product may cause serious adverse health consequences, including shortness of breath, a drop in oxygen levels (desaturation), and death.  There has been one reported injury. There have been no reports of death. The FDA has identified the recall as Class 1, the most serious type. 

[RELATED: Baxter Recalls Life2000 Ventilators]

The Life2000 Ventilation System is intended to provide continuous or intermittent breathing support for people who require mechanical ventilation assistance. The system delivers positive pressure ventilation through a tube inserted into the trachea or through a mask placed over the face. It can also deliver assist/control ventilation. It is used in both home and health care settings.

This recall involves updating instructions for using devices and does not involve removing them from where they are used or sold. 

Affected Product

  • Product Name: Life2000 Ventilators 
  • Unique Device Identifier (UDI)/Model: 00887761978089/ MS-01-0118 or 0081541002053/ MS-01-01187
  • Lot/Serial Numbers: All Life2000 Ventilators with software version 06.08.00.00   

What to Do  

On Sept 12,2024, Baxter Healthcare sent all affected customers an Urgent Medical Device Correction letter recommending the following actions: 

  • Ensure the Life2000 ventilator is connected to a pressure gas source (Life2000 compressor, oxygen cylinder, or wall source) before it is turned on.
    • Refer to setup instructions in the Quick Reference Guide, pages 11 to 13.
  • Review the Quick Reference Guide, instructions for use, and other information 
  • Respond to the notification based on the instructions included in the letter based on the type of user (see for home care users/patients and for healthcare providers/patients below).
  • If product was received from a distributor or wholesaler, respond according to that supplier’s instructions. Response through the Baxter customer portal is not available. 

For home care users/patients 

  • Acknowledge receipt of the notification as shown on the Home Patient Reply Form Instruction Sheet included with the letter.
    • Prompt acknowledgment will prevent repeat notifications, including a phone call from On Process Technology on behalf of Baxter. 
  • If product was received from a distributor or wholesaler, respond according to that supplier’s instructions. Response through the Baxter customer portal is not available. 

For healthcare providers and patients 

  • Acknowledge receipt of the notification through the Baxter customer portal https://BaxterFieldActionCustomerPortal.onprocess.com.
    • Log in to the portal using the account number listed in the reply form instruction sheet included with the letter. 
    • Prompt acknowledgment will prevent repeat notices, including a phone call from OnProcess Technology on behalf of Baxter to confirm receipt.

Customers in the US with questions about this recall should contact Advanced Respiratory Inc Acute Care customer service at the following phone numbers:

  • Health care providers/customers: 800-426-4224, option 2.
  • Home care/patients: Home Care Customer Service 800-426-4224, option 3. 

Photo caption: Life2000

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