Federal health officials have issued their strongest warning possible about the dangers associated with using the B. Braun Infusomat Space Infusion System.
The Food and Drug Administration has issued a Class I recall on these infusion pumps. Use of a medical device included in a Class I device indicates the agency believes use of it could result in serious injury or death. This recall was initiated when it was learned that the anti free flow clip catch located inside the infusion pump door can break when the device is in use.
When the clip catch breaks, it will allow free flow of drugs being administered through the B. Braun device. The drugs administered through this device may have a “narrow therapeutic range” and unchecked flow of it could result in death.
The B. Braun Infusomat Space Infusion System included in the recall was distributed between Nov. 6, 2008, and Dec. 29, 2011. The company is working with its customers to replace the defective clip catch with a metal device that will prevent the defect from occurring.
On some models, the door jamb that was designed to prevent breakage will be removed because it does not perform its intended task. These devices are primarily used in hospital settings.