The FDA has issued an alert regarding two lines of hemodialysis tubing sets from B. Braun Medical following an urgent medical device correction sent to customers by the manufacturer.
Seven affected SKUs from the Streamline Airless System and B3 Low Volume Bloodline product lines may develop small air bubbles during treatment due to a change in tubing resin, according to the March 25 notice. The issue begins approximately 60 minutes into dialysis, when degassing causes bubbles to adhere to the arterial line between the patient connector and the blood pump.
The alert advises providers to avoid using the affected devices unless no alternatives are available. If use is necessary, the FDA recommends avoiding high flow rates and retrograde rinseback when bubbles are present and ensuring all staff are informed of the correction.
B. Braun warned that failure to replace a bubble-affected set could result in inefficient treatment or moderate blood loss. In rare cases, that loss may lead to life-threatening events, including death.
As of March 20, B. Braun had not reported any serious injuries or deaths associated with the issue.
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