FDA recall on ventilators ranked ‘most serious’ after patient injury
Baxter is recalling its Life2000 Ventilator system from the market due to a faulty battery charging dongle that could cause the systems to shut off due to a power failure. The dongle has been found to improperly charge the ventilator batteries and in some cases not charge them at all. Baxter wants all of the systems removed from patient care settings and distributor warehouses until the issue is resolved and a new charging dongle is put into place.
The U.S. Food and Drug Administration (FDA) has categorized his recall a Class I, the most serious type, as ventilator failure can intermittently stop working while it’s aiding unconscious patients who need the systems to breathe. There have been no reported deaths. However, FDA reports one patient has been injured.
What is being recalled?
One line of Baxter Life2000 Ventilators is being recalled. The product has a Unique Device Identifier (UDI) of: 00887761978089.
Next steps
The FDA and Baxter advise providers to find an alternative breathing treatment for patients. However, if the recalled Life2000 system is still being used, the battery must be checked for full charge before it’s used on patients. Further, the company said care teams need to monitor the system for alerts and alarms more frequently to ensure it’s operating properly.
Providers and care teams with questions about the alarms and alerts on the system are also advised to call Baxter for more details.
Dongles for the recalled ventilators need to be replaced. Customers with a potentially defective system are advised to immediately contact Baxter support at 800-426-4224, option 2, to obtain a new dongle. This is especially important if damage is found on the charging dongle or if the Life2000 Ventilator system fails to charge as expected.
The company said replacement dongles will be provided after the process to return the defective devices begins.
Healthcare organizations are also asked to post and share the FDA recall notice to increase visibility.
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