Baxter Spectrum IQ Infusion Pump Recall Issued Due To Software Defects
Federal health officials have announced a recall of certain Baxter Spectrum IQ infusion pumps, after the manufacturer warned the devices may experience software defects that cause the pump to suddenly stop delivery critical fluids to patients, potentially resulting in serious and life threatening injuries.
The Baxter Spectrum IQ recall was announced by the U.S. Food and Drug Administration (FDA) on August 24, following two reports of the infusion pumps suddenly failing, after customers made changes to the configuration of their network and server systems.
The Spectrum IQ is an infusion pump used to deliver medications, blood, and blood products into a patient’s body in a controlled manner. The recalled infusion pumps include a “version 9.0” software, which allows care providers to create a drug library of pre-programmed dosing information for specific medications. However, it now appears that a software defect in the infusion pump may lead to mismatched drug information in the libraries when customers make changes to their network configurations.
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Officials are warning the pumps could experience connectivity errors that place stress on the pumps processor when network configuration changes are being made. During such an this event, a “watchdog” system error alarm may activate, indicating the pump has entered a fail-safe mode, which may cause serious adverse health consequences or death depending on the length of delay, medication being infused, the volume and rate of the infusion, patient health condition and comorbidities.
The recall includes the Spectrum IQ Infusion System with Dose IQ Safety Software marked with Product Code: 3570009. The devices were manufactured by Baxter International Inc. of Deerfield, Illinois and were distributed to hospitals and medical facilities across the U.S. from February 1, 2018 to January 1, 2019
Baxter International issued an Urgent Device Correction on August 2, warning 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 to reduce the likelihood of encountering an issue.
Clinicians are being instructed to immediately power cycle the device if the watchdog system error occurs and to ensure backup devices are readily available when infusing critical medications where interruptions could cause serious injury or death.
The manufacturer announced it 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.
According to Baxter, the software upgrade is expected to be available by the fourth quarter of 2021, and the manufacturer will notify customers and work with them to schedule the upgrades.
Customers with questions concerning the recall are encouraged to contact Baxter sales representative or Baxter Technical Assistance at 800-356-3454. Any and all adverse events should be reported immediately to Baxter Product Surveillance at 800-437-5176 or to the FDA MedWatch Adverse Event Reporting Program.
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