Baxter Healthcare has recalled two of its infusion pump products after software issues meant the devices were issuing false alarms. The US Food and Drug Administration (FDA) tagged this as a Class I recall, indicating risk of injury or death with continued use of the devices.
On 15 June, Baxter Healthcare sent affected customers an urgent device correction letter after receiving 131 complaints about the false alarms.
The recalled devices span those distributed from September 2015 to May 2023.
The two products recalled – the SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) – are software-controlled pumps that deliver therapies like pharmaceutical drugs or blood products in controlled amounts into veins.
There have been reported false alarms for upstream occlusion after recent software upgrades to the devices. These alarms can interrupt therapy and are particularly serious for patients receiving life-sustaining medications. The FDA said in a recall alert that “use of these products may lead to serious injury or death.”
Baxter has issued recommendations related to the issue. The company said to follow instructions in the operator’s manual and, if an upstream occlusion alarm cannot be resolved, to unload the reload the set.
Baxter is also scheduling a software reversion for the affected pumps. The reversion will go to the penultimate software version.
The recall adds to a recent Class I recall for the previous software version which resulted in the pumps potentially not alarming for repeated upstream occlusion events.
By Robert Barrie