Baxter has issued a recall for over 2,500 Life2000 ventilation systems in the United States due to the risk of the devices failing to charge or only intermittently charging. This recall has been categorized by the Food and Drug Administration (FDA) as a Class I event, which denotes the highest level of severity, according to an FDA database entry dated June 26. At this time, Baxter has not provided a comment on the recall.
The Life2000 Ventilation System is designed as a portable ventilator to assist patients suffering from chronic respiratory failure or other conditions impacting their ability to breathe. Baxter acquired the Life2000 system through its $10.5 billion acquisition of Hillrom in 2021, a move that expanded its portfolio of medical devices.
Central to the current issue leading to the recall are damages to the battery charger dongles used with the Life2000 systems. These damages can hinder the ventilator’s internal battery from properly charging. On May 29, Baxter reached out to its customers, including both patients and healthcare providers, alerting them to inspect their devices for any signs of damage to these dongles. The company instructed those with damaged chargers to prepare an alternate ventilatory support or oxygen device for immediate use and to replace the faulty chargers promptly.
Moreover, Baxter emphasized the importance of monitoring for any alarms that might be set off by the system, indicating potential issues. However, patients whose devices are not impacted by damaged dongles and exhibit normal charging behavior are advised that they can continue using their Life2000 units without restrictions. Baxter also reassured that it would replace any damaged devices during the next in-home visit by a clinical trainer scheduled for affected patients.
Additionally, a previous recall involving the Life2000 system occurred in 2023, also stemmed from a significant risk—this time relating to patient oxygen desaturation linked with the use of third-party oxygen concentrators. While there were hospitalizations reported in relation to this issue, Baxter confirmed that there were no deaths caused by this specific problem.
This is not the first instance of recalls concerning products from Hillrom since Baxter’s acquisition. Notably, in 2022, the Volara ventilator system, another product under the Baxter umbrella post-acquisition, was recalled following reports linking the device’s malfunction to two deaths and one injury.
These serial issues with Hillrom devices post-acquisition highlight ongoing challenges Baxter faces in ensuring the reliability and safety of its expanded product line, impacting its reputation and necessitating rigorous scrutiny and improvements in device safety protocols.
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