Baxter issued an Urgent Medical Device Correction notice to affected customers recommending all Volara System patient circuits be corrected prior to continued use, according to an FDA alert.
The Volara System is intended for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis, and has the ability to provide supplemental oxygen when used with an oxygen supply. Volara System is intended to deliver therapy to adults and children over the age of two in the acute care setting, and to adults and children over the age of five in the home care setting.
The FDA says Baxter stated that Volara System single-patient use circuits may experience air and medication leakage from the nebulizer cup during therapy. The leakage can lead to patient desaturation and ineffective nebulization, impacting the delivery of prescribed therapy.
The issue has been associated with improper locking of the nebulizer after medication is added to the cup. If the nebulizer cup is damaged or is not properly engaged during assembly, this issue could lead to medication leakage and ineffective delivery of therapy, according to the FDA.
As of May 21, Baxter has reported one serious injury and no deaths associated with this issue, the FDA says.
Affected Devices
| Product Description | Product Code | UDI-DI |
|---|---|---|
| VOLARA P.CIRCUIT KIT, HC | M08085 | 00887761985018 |
| VOLARA P.CIRCUIT 5KIT | M08270 | 10887761985015 |
| VOLARA P.CIRCUIT KIT AC | M08473 | 00887761981492 |
| VOLARA P.CIRCUIT 5KIT AC | M08474 | 10887761981499 |
FDA Recommendations
Carefully inspect the nebulizer cup for damage before each use. Ensure the nebulizer cup is full and securely locked during assembly. If leakage is observed, discontinue the use of that nebulizer and replace the patient circuit.
On May 21, Baxter sent all affected customers a letter recommending the following actions:
- Before each use, carefully inspect the nebulizer cup for damage and ensure it is fully and securely locked during assembly, following the instructions enclosed in Baxter’s Urgent Medical Device Correction notice.
- If leakage is observed during therapy, discontinue the use of that nebulizer and replace the patient circuit.
- Home Care Patients: If leakage persists or you are unsure whether to continue therapy, contact your healthcare provider or care team for guidance
- Nebulizer cups with patient circuits are routinely replaced as part of normal therapy usage. Additional patient circuits can be provided through standard distribution.
- If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them.
- If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this urgent medical device correction. Please continue distributing this communication to all new customers until the IFU updates are complete. Baxter will advise when the new IFU is released.
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
