The FDA is informing consumers of an Urgent Medical Device Recall announced by Baxter International Inc. regarding its Life2000 ventilators that come with an attached battery charger dongle.
Initiated by the Deerfield, Illinois-based company on July 10, 2024, the recall is a response to reports indicating that damage to the battery charger dongle is not allowing the devices to properly charge. One of the complaints received to date of the FDA announcement described a serious injury potentially connected to the problem. At this time, Baxter is working to facilitate replacements for all affected devices.
Officials have identified that the damage to the device’s battery charger dongle could impede the internal battery of the Life2000 ventilator from attaining and/or holding a charge. A failure to charge or a tendency toward intermittent charging may prevent the patients who rely on ventilator support from using it. This could then lead to “oxygen desaturation episodes,” putting patients at a range of risks, from the mild to the life-threatening. Because of these risks, it is advised that patients have another readily available means of ventilation or oxygen therapy.
Since the recall announcement, affected Baxter customers have been instructed to inspect the state of their device’s battery charger dongle to confirm the device’s charging function is working correctly. In the event that the device is damaged or is not holding a charge, patients are advised to reach out to Baxter Home Care Customer Service for an immediate device replacement. If the device does not appear to be damaged and is charging properly, the ventilator may continue to be used until a Baxter clinical trainer is able to replace the device during the next scheduled in-residence visit.
The Urgent Medical Device Recall covers Life2000 ventilators with attached battery charger dongles that were distributed across the U.S. from August 21, 2023 to April 2, 2024. Affected devices are listed under product code MS01-0118.
Consumers with product complaints or those who have experienced adverse events related to the issue are urged to report them to Baxter through one of the following two channels:
- Baxter Home Care Customer Service, at 800-426-4224, option 3, from 7:30 a.m. to 6:00 p.m. Central Time.
- Baxter Clinical Support, at 800-397-9071, 24 hours a day.
The FDA MedWatch Serious Injury Reporting Program can also be notified. Users have the option of
- filling out and submitting an online report,
- mailing/faxing a downloaded form from the FDA link listed in the announcement, or calling 800-332-1088 to request the specific form,
- then either mailing the completed form to the address on the pre-addressed form, or
- submitting the form via fax to 800-332-0178.
If you or a loved one has suffered an adverse health outcome due to the use of a compromised medical device, your family deserves justice and fair compensation. Our compassionate attorneys at TruLaw are personally invested in fighting for your rights and holding negligent parties responsible. To learn more about how we can support you in the next steps, contact us or take our free Instant Case Evaluation ℠ today.