食品药品监管局发早期警报：Intersurgical 呼吸管接头可能脱落致通气中断 相关批次被要求停用退回
美国食品药品监管局（FDA）11月10日发布早期警报：Intersurgical 公司生产的部分22毫米光面呼吸管与呼吸系统的软质接头可能在使用中脱落，导致患者通气中断，相关批次产品已被要求立即停用、隔离并退回该公司。这批呼吸管用于把患者与呼吸机连接，向患者输送空气与氧气并排出呼出气体。
受影响产品共11个型号，包括单根呼吸管、带水汽收集器的单加热丝与双加热丝呼吸系统、带监测管路与呼气阀的呼吸系统以及双水平呼吸系统等，各型号列有具体批次号。Intersurgical 公司已于11月3日致信受影响客户，要求立即停止使用并隔离涉事批次库存、把产品退回公司，并把通知转达院内所有使用人员与已分销客户。
FDA 表示，这批产品在制造中以四氢呋喃溶剂把软质接头粘合到呼吸管上；美国以外市场报告接头与管体脱开后，公司对内部库存检测发现，部分产品使用的溶剂过少、粘合不牢。接头一旦在使用中脱落，患者可能失去通气或通气受损，血氧下降，直至人工恢复通气；视患者个体情况与恢复通气的时长，通气中断可能导致器官衰竭、脑损伤或因缺氧死亡。
截至11月3日，Intersurgical 公司报告尚无与这一问题相关的严重伤害或死亡。FDA 表示正审查这一潜在高风险器械问题，将在有重要新信息时更新通报。美国境内客户如遇到不良反应或质量问题，可联系该公司客户服务部门，医护人员与消费者也可通过 FDA 的 MedWatch 安全信息与不良事件报告项目报告。
（来源：美国食品药品监管局）
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)
来源：美国食品药品监管局
发布：GSM·美国（发布链接）
图片来源：图：美国食品药品监管局白橡树园区一号大楼（马里兰州）。照片：美国食品药品监管局，公共领域，取自 Wikimedia Commons。 / Photo: Building 1 at the U.S. Food and Drug Administration's White Oak campus in Maryland. Photo by the U.S. Food and Drug Administration, public domain, via Wikimedia Commons.
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