FDA早期警示：B. Braun下架三批Dialog+血液透析管路套装，透析器接头粘合不足可能脱落漏血
美国食品药品监督管理局（FDA）10月27日发布早期警示：B. Braun 已要求下架其 Streamline Bloodline Set for Dialog+ 血液透析管路套装的三个批次（型号 SL-2010M2096，批次 A2600099、A2600128、A2600136），原因是组装时一道必需的溶剂涂布工序没有执行，透析器接头粘合不足，治疗中接头可能脱落或渗漏；FDA 称这是潜在高风险器械问题，截至10月10日尚无与此问题相关的严重伤害或死亡报告。
FDA 介绍，该管路套装用于 Dialog+ 血液透析系统。粘合不足可导致动脉管路在预冲或透析治疗期间脱落、部分分离或渗漏，造成体外循环失血、管路凝血堵塞或空气进入血液回路；治疗可能被迫中断并更换管路，失血可能需要临床评估、纠正治疗、医疗干预或住院，严重失血可危及生命。空气进入血液回路通常会被透析机的空气检测系统发现并由医护处理，但在极罕见情况下，漏过检测的空气可能造成空气栓塞并导致死亡。
B. Braun 已于10月20日致函所有受影响客户，要求告知机构内所有使用者及其他相关人员，经销商应把通知转给收货方；客户应清点库存、停用并隔离受影响产品，并将其退回生产商。FDA 表示正在审查这一潜在高风险问题的信息，并将随重要新信息更新警示页面。
在美国的客户如有不良反应、质量问题或疑问，可发邮件至 [email protected] 或拨打 (610) 849-1197 联系 B. Braun；医护人员和消费者也可通过 FDA 的 MedWatch 计划报告不良反应或质量问题。受影响产品的唯一器械标识（UDI-DI）为 04046964367786 与 04046964367779。
FDA Early Alert: B. Braun Removes Three Lots of Streamline Bloodline Sets for Dialog+ Over Connector Bonding Failure
The U.S. Food and Drug Administration (FDA) issued an Early Alert on October 27, 2026, saying B. Braun has recommended that certain Streamline Bloodline Sets for Dialog+ be removed from where they are used or sold: model SL-2010M2096, lots A2600099, A2600128 and A2600136. The FDA said a required solvent application step during assembly was not performed, resulting in inadequate bonding of the dialyzer connector, which may detach or leak during priming or dialysis treatment. The agency called it a potentially high-risk device issue; as of October 10, B. Braun had reported no serious injuries or deaths associated with the issue.
The bloodline set is a blood tubing set indicated for hemodialysis with the Dialog+ system. According to the FDA, if the arterial tubing detaches, partially separates or leaks during treatment, blood may be lost from the extracorporeal circuit and treatment may need to be interrupted while the bloodline is replaced; blood loss may also occur due to clotting and occlusion of the bloodline. Hemodialysis patients are medically fragile, and extracorporeal blood loss may require clinical assessment, corrective treatment, professional medical intervention or hospitalization, and in severe cases significant blood loss could be life-threatening. Inadequate bonding may also permit air entry into the blood circuit; the air is expected to be detected by the dialysis machine's air detection system and managed by healthcare personnel, but in extremely rare circumstances air passing the detection system could result in air embolism and death.
On October 20, 2026, B. Braun sent a letter to all affected customers recommending that all users be informed of the recall, that distributors forward the notice to their consignees, and that customers determine their inventory, cease use, quarantine the affected product and return it to the manufacturer. The FDA said it is currently reviewing information about the issue and will update the alert page as significant new information becomes available.
Customers in the United States with adverse reactions, quality problems or questions should contact B. Braun at [email protected] or (610) 849-1197. Health care professionals and consumers may also report problems to MedWatch, the FDA Safety Information and Adverse Event Reporting Program. The affected devices carry UDI-DI numbers 04046964367786 and 04046964367779.
来源：GSM·美国（原文链接）
图片来源：血液透析机（资料图）。Jackhsiao 摄，公共领域，经 Wikimedia Commons。 / A hemodialysis machine (file photo). Photo by Jackhsiao, public domain, via Wikimedia Commons.
