​Hillrom—Volara Systems: Oxygen Desaturation or Barotrauma May Occur When Used with In-Line Ventilator in Home Care Environment [FDA Class I]

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Problem:

In an April 26, 2022, Urgent Medical Device Correction letter, Baxter states that a patient's or caregiver's potential lack of awareness of a possible risk of decrease in oxygen levels (oxygen desaturation) or injury may result in lung tissue damage caused by over-expansion (barotrauma) when the above systems are used in the home care environment. These potential events may occur while using the Volara device in line with a ventilator with the required Volara ventilator adapter (OPTIMUS Handset 2) or Volara patient circuit kit (OPTIMUS OLE AC Patient Circuit Kit). Hillrom also states that a home care patient or caregiver can set up their Volara device in line with a homecare ventilator for oscillation and lung expansion (OLE) therapy. The added flow and pressure from the Volara device may interfere with the accuracy of the therapy provided by the ventilator. The patient may be unaware that the...