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The U.S. Food and Drug Administration (FDA) is aware that Baxter has issued an Urgent Medical Device Correction notice to affected customers recommending all Volara System patient circuits be corrected prior to continued use.
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.
As of May 21, Baxter has reported one serious injury and no deaths associated with this issue.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at 1-800-426-4224 and select option 2. For clinical assistance with your Volara therapy, please contact Baxter’s Clinical Support team at 1-800-397-9071.
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