The U.S. Food and Drug Administration (FDA) has issued an "Early Alert" regarding Medline Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits due to reports of electrical connector failures. Medline has advised customers to remove all affected circuits from use or sale.
The issue involves the heated wire connector at the Neptune humidifier, which may show signs of thermal damage such as discoloration, melting, or smoke. While the Neptune humidifier has safety features to cut power to the heated wires upon detecting abnormalities, respiratory gas flow to the patient continues.
However, the continued delivery of inadequately heated or unconditioned gas poses risks to infants, including airway damage, bronchospasm, and obstruction. Loss of heated wire function can also lead to increased circuit condensation, potentially causing inadvertent positive end-expiratory pressure (PEEP) or accidental fluid lavage into the infant's airway. Reduced humidity and cold, dry gas increase the risk of cold stress and worsening respiratory distress.
As of July 31, Medline has not reported any serious injuries or deaths associated with 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 FDA plans to provide updates as new information becomes available.