Baxter Points Correction for Life2000 Ventilator Because of Battery Charger Defect

RT’s Three Key Takeaways:

1. Baxter is changing defective battery chargers in Life2000 ventilators – A producing defect within the charger connector can set off alarms that render the gadget unusable.
2. Customers are suggested to have backup air flow choices – If a ventilator turns into inoperable, sufferers could also be liable to hypoxia, which may result in critical well being penalties.
3. No accidents or deaths have been reported – Baxter has notified affected prospects and is arranging for the return and alternative of faulty chargers.

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

This can be a results of a failed crimping operation throughout manufacturing that triggered the crimp to puncture the insulation of the charger connector, thus leading to an audible and visible alarm, which when engaged makes the ventilator inoperable. The alarm is a high-pitched sound with repetitive beeping and a visible crimson flashing LED icon, alerting the consumer to a problem with the gadget. 

Baxter has corrected the problem, and a Baxter consultant will present a alternative charger in addition to organize for the return of the faulty battery charger.

Using affected product could trigger critical adversarial well being penalties, together with deterioration in respiratory standing, resulting in hypoxia, with ensuing cognitive impairment, lethargy, adjustments in blood stress and coronary heart operate, and even coma and loss of life.

If the affected person is just not shortly transitioned to an alternate technique of air flow or oxygen remedy, additional lung injury may happen relying on the consumer’s pre-existing medical situation and entry to their beneficial back-up gadget or oxygen remedy. There have been no reported accidents. There have been no stories of loss of life. 

The Life2000 air flow system is meant to offer steady or intermittent ventilatory assist for the care of people who require mechanical air flow.

Affected product:

• Product Names: Life2000 Ventilator System
• Mannequin/Distinctive Gadget Identifier (UDI):
  • Mannequin #  |  Distinctive Gadget 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

At all times have an alternate technique of air flow or oxygen remedy obtainable. Sufferers could proceed utilizing the Life2000 ventilator whether it is functioning accurately.

On Dec 20, 2024, Baxter Healthcare Corp despatched all affected prospects an Pressing Medical Gadget Correction letter recommending the next actions:

• For those who obtained this communication immediately from Baxter, acknowledge receipt of this letter, even when you shouldn’t have any remaining stock.
  • If you don’t full the acknowledgment, you’ll obtain a cellphone name from OnProcess Know-how on behalf of Baxter to verify your receipt of this notification.
• For those who distributed this product to different services or departments inside your establishment, please ahead a duplicate of this communication.

Prospects within the US with questions on this recall ought to contact Baxter Superior Respiratory, Dwelling Care Buyer Service staff at 800-426-4224, possibility 3, between the hours of seven:30 am and 6 pm CT, Monday by Friday. Alternatively, contact Baxter Superior Respiratory, Scientific Assist staff at 800-397-9071.

Well being care suppliers with questions on this recall ought to contact Baxter Superior Respiratory staff at 800-426-4224, possibility 2, then possibility 1, between the hours of 8 am and 6 pm CT, Monday by Friday.

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