What the Heck is Going on at Baxter?

Baxter International, on the heels of its Life2000 ventilator recall, yesterday announced the recall of certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly.

The Volara system, when used in conjunction with a ventilator and without a nebulizer connected to the blue ventilator adapter, is required to have the handset plug to help ensure proper operation and ventilator gas flow. The company is recalling the blue ventilator adapter after reports the handset plug may disconnect from the nebulizer port on the blue ventilator adapter. If this were to happen and go unnoticed prior to or during therapy, it could lead to an interruption or delay in care, resulting in “reduced ventilation and oxygenation due to the ventilator leaking gas flow from the nebulizer port on the blue ventilator adapter,” according to the recall notice.

Baxter has instructed customers to stop using the blue ventilator adapter. If a patient does not have another therapy option, the company said, “they may continue to use it with caution. Customers are instructed to visually inspect the nebulizer port prior to therapy and check for any ventilator gas flow leaks for the duration of therapy.”

The recall applies to the Volara system single-patient use circuit with product codes M08473 and M08474, and the blue ventilator adapter assembly with product code M07937. Affected product was distributed between Aug. 26, 2022, and Dec. 30, 2023. Currently, no injuries have been connected to the issue.

Earlier this week, MD+DI reported that Baxter also initiated a recall for its Life2000 ventilators with an attached battery charger dongle.

The company informed customers that when damaged, the battery charger dongle is unable to charge the ventilators internal battery. If it fails to charge, a patient would not be able to use the device. For patients requiring Life2000 support, an inability to use the device could result in oxygen desaturation episodes that range from mild to potentially life-threatening.

Both the Volara and Life2000 ventilators are no stranger to FDA ire. In 2022, Baxter was embroiled in a Class I recall of the Volara after receiving reports of two device-associated deaths. In early 2023, Life2000 had a device correction due to risk of patient oxygen desaturation when connected with a third-part oxygen concentrator.

Baxter declined MD+DI's request for comment.