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The U.S. Food and Drug Administration (FDA) is aware that B. Braun Medical Inc. has sent all affected customers an Urgent Medical Device Correction recommending certain Streamline Airless System Hemodialysis Bloodlines and B3 Low Volume Bloodlines only be used if no alternative is available.
B. Braun Medical Inc. has preliminary testing showing that a change to the tubing resin has led to small air bubbles adhering to the inside of the arterial bloodline, in the segment between the patient connector and the blood pump.
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.
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact B. Braun Medical Inc. at Recalls@bbraunusa.com or 1-833-425-1464.
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