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Early Alert: Nitric Oxide Delivery System Issue from NOxBOX
The FDA is aware that NOxBOX has issued a letter notifying affected customers that certain nitric oxide delivery systems have updated use instructions.
NOxBOX reported complaints of oxygen leaks due to failure of the oxygen tubing or tubing connection within the NOxMixer module of the NOxBOXi device. In some cases, oxygen leaks could result in increased dosage of nitric oxide or interruption in therapy. Potential health consequences for an interruption during therapy include oxygen desaturation and increased pulmonary artery pressure with the associated complications. Increased nitric oxide dosages may lead to methemoglobinemia and its associated complications. Neonates with congenital heart disease are at greater risk than other patients for health complications.
As of August 12, NOxBOX has not reported any serious injuries or 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 issue should contact NOXBOX at NOxBOX_qatech@linde.com.
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