Baxter Life2000 Ventilator Recall Issued Over Battery Charging Problems Linked To Patient Injury
Failures of the Life2000 Ventilator battery charging dongle may cause serious or fatal injuries for patients receiving life-sustaining oxygen.
Federal regulators say a problem with the Baxter Life2000 ventilator may result in the devices failing to charge, and thus failing to provide life-sustaining oxygen to patients, which could put them at risk of sustaining serious injury or death.
The U.S. Food and Drug Administration (FDA) announced the Baxter Life2000 ventilator recall on July 15, indicating that the battery charging dongle may fail. The agency has given it a Class I recall designation, which is the most serious recall classification the agency can assign to a medical device.
The Life2000 is a portable ventilation device designed to provide respiratory support to patients who require mechanical ventilation. To use the device, the caregiver or patient first ensures it is properly charged or connected to a power source. It is then set up according to the prescribed settings, which may include adjusting the airflow, pressure, and timing based on the patient’s specific needs.
For non-invasive ventilation, a mask or nasal cannula is fitted to the patient, while invasive ventilation requires a connection to a tracheostomy tube. The device continuously monitors the patient’s respiratory status and provides real-time feedback and alarms to ensure optimal operation.
Due to the battery charging dongle problems, the device may fail to charge properly. A charging failure means a patient will not be able to use the ventilator properly, which could result in oxygen desaturation episodes that range from mild to potentially life-threatening. At least one injury has already been linked to the problem.
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The recall affects about 2,500 Life200 Ventilator Systems, with product codes BT-20-0002, BT-20-0002A and BT-20-0002AP.
Baxter originally announced the recall to its customers through a May 29 Urgent Medical Device Recall letter. It recommended customers check the ventilator battery for the charge icon while it is plugged into the charging dongle, observe any alarms given off by the devices, and to review the device’s quick reference guide for details about the battery charge and associated alarms.
If customers find they have a unit that fails to charge as expected, or have questions about the recall, they should immediately contact Baxter Acute Care Customer Service Support at 800-426-4224- and choose option 2 to obtain a replacement, the letter stated.
Healthcare professionals and consumers can report adverse reactions or quality issues experienced with these devices to MedWatch, the FDA Safety Information and Adverse Event Reporting Program.
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