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Why B. Braun's Latest Recall Is Serious

Variation in molding parameters caused potential conductivity sensor cracks in certain B. Braun Medical hemodialysis systems.

Nancy Crotti

Dialog+ Hemodialysis System
Dialog+ hemodialysis system (Image courtesy of FDA)

B. Braun Medical has recalled more than 1000 Dialog+ hemodialysis systems due to cracks in conductivity sensors.

The cracks may allow air into the dialysis fluid that helps filter waste and other excess fluids in the blood, according an FDA notice. Although no patients were apparently harmed, the presence of air in the fluid could lead to improper blood filtration, causing serious adverse health consequences, including death. FDA has pegged the recall Class I.

The agency's adverse events reporting site several reports, including one that described the results of a company investigation.The conductivity sensors are in an area of system that is under negative pressure, which allows air to be sucked into the dialysis fluid, the report said. Continuous air entry due to the leakage of the conductivity cells can lead to cyclical pressure fluctuations that can block a filter and cause the system to remove too much fluid from the patient.

The cracking was caused by variation in molding parameters of the flanges used in the sensors' construction, and by thermal and mechanical stress during normal operations, the report added.

The recall affects model numbers 710200L, 710200K, 710200S, 710200U, 710500L, and 710500K, manufactured between  April 1, 2013 and July 3, 2013. The machines were distributed in 29 states, Puerto Rico and the Virgin Islands from June 25, 2013 through October 7, 2015, according to FDA. B. Braun notified customers of the recall by a letter dated April 1.

A company representative did not immediately respond to requests for comment.

The Dialog+ recall is the second for B. Braun in recent weeks. On March 28, the company issued a voluntary nationwide recall of a one lot of a dextrose injection fluid "due to leakage and/or particulate matter identified to be microbial growth...  Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening."

Customers had complained of leaking packaging and particulate matter in the 5% Dextrose Injection USP 100/150 mL containers,but no adverse events were reported, the company said in a statement. FDA did not list this recall on its website.

B. Braun manufactures products for infusion therapy and pain management, including IV solutions, drug delivery systems, clinical nutrition solutions, IV safety catheters, needle-free IV systems, smart IV pumps, dialysis machines and disposables, and pain control catheters, needles, and trays.

Headquartered in Melsungen, Germany, the B. Braun Group of Companies includes subsidiary firm B. Braun Medical in Bethlehem, PA.

Learn more about cutting-edge medical devices at MD&M East, June 14-15, 2016 in New York City.

Nancy Crotti is a contributor to Qmed and MPMN.

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