Baxter is replacing faulty battery chargers in the Life2000 Ventilator system after identifying a defect that triggers alarms and renders the device inoperable.


Summary:

Baxter Healthcare Corp is correcting an issue with the Life2000 Ventilator System due to a defect in the battery charger that can trigger an alarm and render the ventilator inoperable. The defect, caused by a manufacturing error during the crimping process, punctured the insulation of the charger connector, leading to audible and visual alarms that disable the device. While no injuries or deaths have been reported, Baxter has advised users to have an alternative means of ventilation available and is providing replacement chargers.

Key Takeaways:

  1. Baxter is replacing faulty battery chargers in Life2000 ventilators – A manufacturing defect in the charger connector can trigger alarms that render the device unusable.
  2. Users are advised to have backup ventilation options – If a ventilator becomes inoperable, patients may be at risk of hypoxia, which can lead to serious health consequences.
  3. No injuries or deaths have been reported – Baxter has notified affected customers and is arranging for the return and replacement of defective chargers.

Baxter Healthcare Corp is correcting the Life2000 Ventilator System due to a nonconforming battery charger, which triggers a battery alarm and renders the ventilator inoperable. 

This is a result of a failed crimping operation during manufacturing that caused the crimp to puncture the insulation of the charger connector, thus resulting in an audible and visual alarm, which when engaged makes the ventilator inoperable. The alarm is a high-pitched sound with repetitive beeping and a visual red flashing LED icon, alerting the user to an issue with the device. 

Baxter has corrected the issue, and a Baxter representative will provide a replacement charger as well as arrange for the return of the defective battery charger.

The use of affected product may cause serious adverse health consequences, including deterioration in respiratory status, leading to hypoxia, with resulting cognitive impairment, lethargy, changes in blood pressure and heart function, or even coma and death.

If the patient is not quickly transitioned to an alternate means of ventilation or oxygen therapy, further lung damage could occur depending on the user’s pre-existing medical condition and access to their recommended back-up device or oxygen therapy. There have been no reported injuries. There have been no reports of death. 

The Life2000 ventilation system is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

Affected product:

  • Product Names: Life2000 Ventilator System
  • Model/Unique Device Identifier (UDI):
    • Model #  |  Unique Device Identifier (UDI):
      • REF BT-20-0002  |  UDI/DI 00887761978201
      • REF BT-20-0002A and REF BT-20-0002AP  |  UDI/DI 00887761981638
      • MS-01-0118  |  UDI/DI 00887761978089
      • MS-01-0118  |  UDI/DI 00815410020537
  • Lot/Serial Numbers: See Attachment A

What to Do

Always have an alternate means of ventilation or oxygen therapy available. Patients may continue using the Life2000 ventilator if it is functioning correctly.

On Dec 20, 2024, Baxter Healthcare Corp sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:

  • If you received this communication directly from Baxter, acknowledge receipt of this letter, even if you do not have any remaining inventory.
    • If you do not complete the acknowledgment, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.
  • If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication.

Customers in the US with questions about this recall should contact Baxter Advanced Respiratory, Home Care Customer Service team at 800-426-4224, option 3, between the hours of 7:30 am and 6 pm CT, Monday through Friday. Alternatively, contact Baxter Advanced Respiratory, Clinical Support team at 800-397-9071.

Health care providers with questions about this recall should contact Baxter Advanced Respiratory team at 800-426-4224, option 2, then option 1, between the hours of 8 am and 6 pm CT, Monday through Friday.

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