|
Early Alert: Breathing Circuit Issue from Medline
The FDA is aware that Medline has issued letters to affected customers recommending all affected Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits be removed from where they are used or sold.
Medline has received reports of sporadic failures involving the electrical connector of certain neonatal and infant heated wire breathing circuits. In affected circuits, the heated wire connector (pigtail) at the Neptune humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage.
The Neptune humidifier is designed with safety features that continually monitor the heated wire circuit and automatically discontinues power to the heated wires when electrical abnormalities are detected. When power to the heated wires is disconnected, respiratory gas flow to the patient continues. The disconnection of power is limited to the heated wire function.
Continued delivery of inadequately heated or unconditioned gas can desiccate and damage the airway epithelium, predisposing the infant to bronchospasm, inspissated secretions, and airway obstruction. Potential continued loss of heated wire function may result in increased circuit condensation (rainout), which can cause inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the infant's airway. Reduced humidity and delivery of cold, dry gas increases the risk of cold stress, leading to elevated oxygen consumption and worsening respiratory distress. Increased vigilance is recommended for monitoring your ventilator, circuit, and humidification systems.
As of July 31, Medline 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 questions about this recall should contact Medline at (866) 359-1704 or recalls@medline.com.
|
