Monday, July 15, 2024

Baxter Recalls Life2000 Ventilation Systems Due to Charging Malfunctions in FDA Class I Event

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Ventilation systems from Baxter, specifically the Life2000 units, have been recalled due to risks associated with device charging malfunctions. The recall, affecting over 2,500 units distributed in the United States, was classified as a Class I event by the Food and Drug Administration (FDA), indicating the highest level of severity. This action follows a similar recall last year for the Life2000 Ventilation System due to risks of oxygen desaturation.

The Life2000 Ventilation System is a portable ventilator designed for patients with chronic respiratory failure or other conditions impacting their breathing. Baxter acquired this product through its $10.5 billion purchase of Hillrom in 2021. The current recall was prompted by issues related to the battery charger dongles, which may be damaged and thus prevent the internal battery from charging properly.

Baxter Issues Recall for Life2000 Ventilators, Advises Precautions and Offers Replacements

Baxter informed customers, including patients and healthcare providers, of the recall on May 29. The company advised them to inspect the battery charger dongles for any damage and to have an alternative ventilator or oxygen device available as a precaution. Baxter emphasized the importance of monitoring the ventilator system for alarms and instructed that patients could continue using the devices as long as the dongle was intact and the battery was charging correctly. Baxter committed to replacing damaged ventilator devices during the patients’ next scheduled in-home visit with a clinical trainer.

This recall is not the first instance of issues with the Life2000 system. In 2023, Baxter recalled thousands of these systems due to the risk of oxygen desaturation when connected to third-party oxygen concentrators. Although no deaths were reported at that time, there were instances of hospitalizations. Baxter’s history with recalls extends beyond the Life2000 system. Following the acquisition of Hillrom, Baxter also recalled the Volara ventilator system in 2022 after one injury and two deaths were linked to a malfunction of the device.

Ventilation System

Life2000 Ventilation System Recalls Highlight Challenges in Medical Device Reliability and Safety

The ongoing issues with the Life2000 Ventilation System highlight significant challenges in maintaining the reliability of life-supporting medical devices. The repeated recalls underscore the critical need for rigorous quality control and proactive safety measures in the manufacturing and maintenance of such devices. Baxter’s efforts to address these problems include notifying customers promptly, providing guidance on alternative arrangements, and committing to replace faulty equipment.

Baxter’s recall of the Life2000 ventilation systems due to charging malfunctions involves over 2,500 units in the U.S. and is classified as a Class I event by the FDA. The issue arises from damaged battery charger dongles that prevent the internal battery from charging. Baxter has informed customers to check for damages, have backup devices ready, and monitor for system alarms.

This recall follows previous actions for the same device due to oxygen desaturation risks and other Hillrom devices like the Volara ventilator system. These recalls emphasize the importance of stringent quality control in medical device manufacturing to ensure patient safety. Baxter’s response includes customer notifications, replacement of faulty devices, and ongoing vigilance in addressing potential risks associated with their products.

 

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Resource: Food and Drug Administration, June 26, 2024

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