Deerfield, Ill.-based Baxter International Inc. announces that it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this information to customers via an Urgent Medical Device Correction notification on June 4, 2021, and a follow-up communication with updated information External Link Disclaimer on August 2, 2021.
Two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in multiple pump connectivity errors, placing stress on the pump’s processor.
When this occurs, pumps initiate a “watchdog” system error alarm to notify the user of the issue, causing the pump to enter a fail-safe mode which stops all pump processes, including delivery of fluid to the patient. For both customers, the watchdog system errors were resolved by restoring network and server system performance to expected levels.
To date, there have been no reports of adverse events or patient injury associated with this issue, according to Baxter. However, depending on several factors, such as the length of delay, medication being infused, the volume and rate of the infusion, patient status, and comorbidities, the patient may experience serious adverse health consequences or death.
Moreover, Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s memory and processing functions if this occurs. The updated software is currently expected to be available early in the fourth quarter of 2021, and Baxter will work with customers to schedule the software upgrades.
To reduce the likelihood of encountering this issue, Baxter is asking customers to contact Baxter Technical Assistance at 800-356-3454 in advance of making changes to their network or server infrastructure supporting the pumps or the Baxter Gateway. Changes requiring prior notice can be found in the Urgent Medical Device Correction communication and in Baxter’s Gateway Server Installation Handoff document, which customers receive upon installation. Additionally, Baxter recommends that customers ensure backup devices are readily available when infusing critical medications.
For more information, visit the FDA’s website.