Correction: A previous version of this article incorrectly described Baxter's Nov. 29 announcement as an urgent medical device correction letter.
Dive Brief:
- Baxter told customers that its Novum IQ syringe infusion pump may fail to deliver a complete infusion and shared “reinforced guidance” to mitigate the risk.
- After one or more downstream occlusion alarms, the pump may display an “Infusion Complete” alarm despite the syringe still containing fluid. The fault could cause underdosing or interrupt treatment.
- Baxter, which is developing a software fix for the problem, previously contacted customers about the “Infusion Complete” error in October. The Food and Drug Administration tagged that notice as a Class I event.
Dive Insight:
In October, Baxter sent an urgent medical device correction letter to tell customers to check if fluid is still in the syringe after an infusion has completed, especially when “one or multiple downstream occlusions have alarmed.” The company asked users to reprogram the pump if they found fluid was still there after the "Infusion Complete" alarm. The FDA issued a Class I notice about the fault last month.
On Nov. 29, Baxter released a separate announcement of the safety issue, which the FDA shared on its website, referring to the notice from October and outlining how Novum IQ syringe pumps may erroneously report that an infusion is complete after occlusion alarms occur.
The announcement features “reinforced guidance” that Baxter wants users to follow while it works to fix the problem through a software update. Users should choose the smallest compatible syringe size necessary to deliver the fluid or medication and ensure the downstream occlusion pressure setting is appropriate before starting infusion. Baxter is also asking users to monitor infusion volumes during delivery.
Baxter is yet to receive a report of serious injury associated with the problem. However, the potential for underdosing and interruptions to therapy to cause harm led the FDA to issue a Class I notice when it looked into the fault last month.
