Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps.
Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into a person’s body in controlled amounts using the Spectrum IQ infusion pump.
The recall occurred due to a software defect that may lead to mismatched drug information in drug libraries created using version 9.0.x of the computer-based software.
According to an FDA release, two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets after changes were implemented to their network configuration and server systems.
Gateway server system performance anomalies resulted in multiple pump connectivity errors and placed stress on the pump’s processor, the release said, resulting in a “watchdog” system error alarm that notifies the user of the issue and places the pump into a fail-safe mode that stops all pump processes, including infusion to the patient.
Both customers who reported errors had their issues resolved by restoring network and server system performance to expected levels, with no reports of adverse events or patient injury associated with the issue. However, certain factors caused by the issue could result in serious adverse health consequences or death.
The company is developing a software upgrade for all Spectrum IQ infusion pumps to assist the pump’s response to unstable network and server systems by reducing the stress on memory and processing functions.