The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.
B Braun Medical Inc has identified a manufacturing issue where the arterial and venous patient connectors of certain lots of Streamline Bloodline Set for Dialog+ were damaged, which may result in micro-air bubbles in the line and trigger air-in-line alarms, according to a US Food and Drug Administration (FDA) recall alert. This damage creates a pathway for air to enter the extracorporeal circuit and the potential for blood/fluid leakage.
The detection of micro-air bubbles in the line during patient use may require set replacement, resulting in treatment delays, or inadequate or inefficient treatment, according to the alert. In cases where air is pulled into the line, blood in the extracorporeal circuit cannot be returned to the patient and must be discarded, leading to moderate patient blood loss. In some instances, this blood loss may cause a significant change in patient condition requiring immediate treatment.
An opening in the bloodline results in a loss of sterility, potentially leading to bloodstream infections that require medical intervention. In some patients, including critically ill patients, blood loss or potential infection may lead to life-threatening adverse events, including death. Additional risks include air entering the patient circulation, which may lead to air embolism.
The Streamline Bloodline Set for Dialog+ Hemodialysis System is a blood tubing set indicated for use with a medically prescribed hemodialyzer.
The FDA notes that, as of Sept 30, 2025, B Braun Medical Inc has received no reports of serious injuries or deaths associated with this issue. A list of the affected products can be found on the FDA’s website.
ID 84067257 © Zlikovec | Dreamstime.com
