Dive Brief:
- The Food and Drug Administration has categorized B. Braun Medical’s correction of infusion pumps as a Class I event.
- B. Braun contacted customers in September about faulty occlusion alarms that can cause Infusomat pumps to stop working. The fault could stop the delivery of high-risk medications such as vasopressors and lead to serious injury or death.
- The FDA said there have been 51 complaints, one reported injury and one death related to the problem. B. Braun has asked the users of 10,655 pumps to take precautions while it works to fix the fault.
Dive Insight:
Hospitals use Infusomat pumps to administer parenteral fluids, medications, blood and blood products. The pumps provide patients with intermittent or continuous delivery of the liquids. If the pressure goes outside of certain parameters, an alarm sounds to alert healthcare professionals of the need to check for a kink in the tubing or other problem that is causing a blockage.
The Class I notice describes a fault that is causing the occlusion alarm to sound when no blockage exists. The problem causes the pump to stop the delivery of the medication. The clinical significance of a pump stopping depends on the medication being delivered.
As the FDA explains in its notice, “interruption to the infusion of high-risk medications may lead to hemodynamic instability requiring medical intervention to prevent permanent impairment to body structures or body functions.” Such interruptions may be life-threatening or lead to death.
B. Braun sought to mitigate the risk by asking customers to move affected devices that were shipped between Oct. 26, 2022, to July 17, 2023, to areas where only low-risk medication is delivered. A second pump should be available if a high-risk medication is being infused. B. Braun has provided stickers so that customers can mark affected pumps.
The measures are intended to prevent the fault from harming patients as B. Braun works to provide a permanent fix. The company is scheduling services so its technicians can “replace the occlusion pressure sensors with a second source of qualified sensors.”
The recall is the first Class I event for Infusomat pumps since 2019.