Software issue can cause potential harm or death
On March 10, the US Food and Drug Administration (FDA) announced that Baxter International Inc. has issued an urgent medical device correction for its LIFE2000 Ventilation System. An issue with the device’ software may cause potential harm or death to the patient. This post provides a summary of the FDA announcement and steps being taken to address the issue.
Software issue and potential risks
The problem with the LIFE2000 Ventilation System is related to a software glitch that could cause the ventilator to reset during patient use, leading to a temporary disruption of ventilation support. The disruption may result in hypoventilation, hypoxemia, or hypercarbia, which could cause patient harm or even death. The FDA has classified this as a Class I recall, the most serious type, due to the potential for serious injury or death.
Affected devices and distribution
The affected devices include the LIFE2000 Ventilation System and its associated components, such as the LIFE2000 Compressor and LIFE2000 Humidifier. The systems were manufactured between January 1, 2016, and September 9, 2021, and distributed from January 1, 2016, through September 9, 2021. Baxter has identified a total of 19,056 affected units worldwide, with 1,066 of these units distributed within the United States.
Actions taken by Baxter
Baxter has sent an Urgent Medical Device Correction letter to all affected customers, informing them of the issue and providing instructions on how to mitigate the potential risk. The company has advised healthcare professionals to update their LIFE2000 Ventilation Systems with a new software version (Version 2.2.3) that addresses the problem. Baxter has also provided a technical support hotline for customers to call for assistance with the software update.
Recommendations for healthcare professionals
Healthcare professionals using the LIFE2000 Ventilation System are advised to follow the recommendations provided by Baxter. These include:
- Review the Urgent Medical Device Correction letter and ensuring that all staff members are aware of the issue.
- Update the software on all affected LIFE2000 Ventilation Systems to Version 2.2.3.
- Monitor patients closely during the software update process to ensure proper ventilation support is maintained.
- Report any adverse events related to the use of the LIFE2000 Ventilation System to the FDA’s MedWatch Adverse Event Reporting program.
Conclusion
The FDA announcement of Baxter’s urgent medical device correction for the LIFE2000 Ventilation System highlights the importance of timely software updates and proper monitoring of medical devices. Healthcare professionals using the affected devices should take immediate action to mitigate the potential risks to patients. By staying informed and following the guidance provided by the FDA and Baxter, healthcare providers can help ensure the safety of their patients.
FDA Announcement
Read the complete FDA announcement here.