The Food and Drug Administration has issued a Class I recall on the B. Braun Infusomat Space Infusion System because it could break while in use, posing serious injury risks to patients.
The FDA reserves Class I recalls for when it believes use of a medical device could result in serious injury or death to a patient. According to the agency’s recall notice, the B. Braun Infusomat Space Infusion System has the potential “for breakage of the anti free flow clip catch located inside the infusion pump door.”
This malfunction can occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed, according to the statement. A misload of this device can lead to a free flow of medication. A free flow of medications commonly delivered through the B. Braun Infusomat Space Infusion System, such as “narrow therapeutic drugs”, can result in life-threatening side effects.
Pumps affected by this recall were distributed between Nov. 6, 2008, and Dec. 29, 2011. These pumps are used to deliver intravenous (IV) infusions of fluids, medications, blood, and blood products to adult, pediatric, and neonatal patients, the FDA indicates in its recall statement. These devices are commonly used in hospital settings.
B. Braun is working with the FDA on the recall by contacting customers and inserting existing devices with a metal clip catch, an upgrade on the model currently available. The metal clip catch will eliminate the possibility of breakage, the reason for the recall.
There is no indication of any injuries or deaths associated with these infusion pumps malfunctioning.