Baxter’s efforts this summer to correct high-risk issues with its infusion pumps has gotten more complicated.
Last month, the company and the FDA alerted the public to a problem with the large-volume version of its Novum IQ pump, which could cause it to under- or overdeliver IV medications. The agency said July 22 that it had received reports of 79 serious injuries and two deaths.
Now, the FDA is getting the word out on separate software issues that can affect both the large-volume Novum IQ as well as its smaller, syringe-based pump.
Baxter sent a letter to healthcare providers with correction instructions on August 4, saying users should consider employing an alternate pump if available and appropriate, but that the Novum IQ LVP and Novum IQ syringe pump can still be used by taking proper care to ensure the accurate delivery of fluids.
According to the company, software bugs may cause a blank Run screen in both the LVP and syringe pump models—as well as a false motor movement system error in the syringe pump only.
The blank Run screen can be triggered in different ways; for example, if a clinician clears a downstream occlusion alarm while the device is automatically restarting the infusion. The company said the issue will not interrupt ongoing therapy, which will run to completion, but the user will not be able to make adjustments to flow settings. Doses will have to be stopped while the pump door is opened for corrections or the syringe reloaded, or while the pump is power cycled for a reset.
The false motor movement system error in the syringe pump, meanwhile, can occur after programming specific dose or flow rate changes, while the system is running below the minimum recommended flow rate for syringes 10 mL or larger.
The company and the FDA have published a chart of which dosing changes to avoid—tied to compatible syringes from BD, as well as Cardinal Health’s Monoject and Avanos Medical’s Neomed hardware, across multiple sizes. The agency recommended printing the chart and posting it in break rooms as well as where pumps are stored and used.
Baxter said that, as of July 21, it has received three reports of serious injuries and no deaths.
The previous issue affecting the Novum IQ large-volume pump was linked to transitioning from a low flow rate to a higher one, specifically when the rate change is more than double, with the ultimate impact based on the differences between flow rates and how long the machine was running at the previous setting.
At the end of last month, during its second-quarter earnings report, Baxter said it has paused planned installations of the Novum IQ LVP as it sorts out the issue. No hardware needs to be returned to the manufacturer at this time.
The company said July 31 that its goal is to resume shipments by the end of the year, but that it could not commit to an exact timeline.