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Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information Regarding Best Practices for Customer-Initiated IT Network Updates

September 30, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) has been informed by U.S Food and drug administration (FDA) about a safety communication that Baxter International Inc. 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 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 date, there have been no reports of adverse events or patient injury associated with this issue. 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.

PRODUCT DETAILS

Product code Product description Serial Number
3570009 Spectrum IQ Infusion system with dose IQ safety software All

HEALTHCARE PROVIDER’S ACTIONS 

NAFDAC implores healthcare professionals in possession of the Spectrum IQ Infusion system to reinforce important safety information when changes is implemented to their network configuration and server systems.

Health professionals and patients are encouraged to report adverse events or quality problems experienced with the use of these medicines to the nearest NAFDAC office, NAFDAC PRASCOR [20543 or 0800-1-NAFDAC (0800-1-623322) TOLL FREE from all networks] or via pharmacovigilance@nafdac.gov.ng or via eReporting platform available on the NAFDAC website www.nafdac.gov.ng or via Med Safety Application available for download on Android and IOS stores. 

NAFDAC……..Customer-focused, Agency-minded!!!

Signed Management

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