The FDA said that B. Braun Medical Inc. has issued an Urgent Medical Device Correction to affected customers recommending certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines. The company said the tubing should only be used if no alternative is available.
B. Braun's preliminary testing has shown that a change to the tubing resin has resulted in small air bubbles adhering to the inside of the arterial bloodline, in the segment between the patient connector and the blood pump. These bubbles are the result of degassing of blood on the arterial side of the blood pump due to the negative pressure within the tubing and are not being drawn into the bloodline from the external environment. With the previous tubing resin, these bubbles remained in the blood and were compressed or dissolved via the positive pressure applied post blood pump. With the new resin, these small bubbles adhere to the inside of the bloodline and may gather to form larger bubbles. This process of degassing and bubble formation normally begins approximately 60 minutes into dialysis treatment.
The company warned that air bubbles detected in the line during use may lead to a delay in treatment to replace the set and resume therapy. If the operator does not replace the set, it may result in less efficient treatment. If the safety air detector in the dialysis machine detects the bubbles, the machine will alarm and automatically stop treatment. The operator must respond to the alarm to continue treatment, which may include replacing the set and/or monitoring treatment.
Patients may experience moderate blood loss if it is not clinically feasible to return the blood in the extracorporeal circuit to the patient. In some patients, blood loss may lead to life-threatening adverse events, including death.
As March 20, 2026, B. Braun Medical Inc. has not reported any serious injuries or deaths associated with this issue.
