The U.S. Food and Drug Administration (FDA) has issued an "Early Alert" regarding certain nitric oxide delivery systems from NOxBOX due to reported oxygen leaks that could lead to serious health complications.
NOxBOX notified customers about updated use instructions after receiving complaints of oxygen tubing or connection failures within the NOxMixer module of the NOxBOXi device. These leaks could result in either an increased dosage of nitric oxide or an interruption in patient therapy.
Potential health consequences include methemoglobinemia from increased nitric oxide, and oxygen desaturation or increased pulmonary artery pressure from therapy interruption. Neonates with congenital heart disease face a higher risk. As of August 12, NOxBOX has not reported any serious injuries or deaths related to this issue.
The FDA's Center for Devices and Radiological Health (CDRH) said, "CDRH is issuing this 'Early Alert' to notify the public of a potentially high-risk device issue." The agency plans to provide updates as new information becomes available.