FDA Issues Early Alert: Intersurgical Breathing Tube Connectors May Detach, Cutting Ventilation; Affected Lots to Be Removed
The U.S. Food and Drug Administration (FDA) on Nov. 10 issued an early alert that soft connectors on certain 22mm Smoothbore breathing tubes and systems made by Intersurgical Inc. may disconnect during use, cutting off a patient's ventilation, and that affected lots should be immediately removed from use, quarantined and returned to the company. The tubes connect patients to machines that help them breathe, carrying air and oxygen to the patient and allowing exhaled air to flow out.
Eleven product models are affected, including a single breathing tube, single and dual heated-wire breathing systems with water traps, breathing systems with monitoring lines and exhalation valves, and bilevel breathing systems, each with listed lot numbers. On Nov. 3, Intersurgical sent a letter to affected customers recommending they immediately discontinue use and quarantine affected stock, return the product to the company, and share the notice with all users in their facilities and with any customers who received the products.
The FDA said tetrahydrofuran solvent is used during manufacturing to bond the soft connectors onto the tubes. Following reports from markets outside the United States of connectors disconnecting, testing of internal stock found some products were made with too little solvent to ensure a secure connection. If a connector disconnects during use, a patient could lose ventilation and desaturate until ventilation is manually restored; depending on the patient and the time needed to restore ventilation, the loss could lead to organ failure, brain damage or death from hypoxia.
As of Nov. 3, Intersurgical had reported no serious injuries or deaths associated with the issue. The FDA said it is reviewing the potentially high-risk device issue and will update the public as significant new information becomes available. Customers in the United States with adverse reactions or quality problems can contact the company's customer service, and health professionals and consumers may report problems through the FDA's MedWatch program.
(Source: U.S. Food and Drug Administration)
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
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