According to a recall notice published on August 24, 2021, the United States Food and Drug Administration announced that Baxter International Incorporated had issued an urgent medical device correction for its Spectrum IQ Infusion Pumps. The update includes information that reinforces safety instructions concerning “customer-initiated IT network updates.” The FDA stated that the specific cause of the recall was “Multiple Connectivity Errors.”
According to the announcement, two Baxter Spectrum IQ Infusion Pump clients informed Baxter of network system errors happening to several pumps within their group after customers implemented changes to the configuration of their server systems and networks. The FDA’s notice also stated that the Gateway Server System sustained irregularities that caused multiple pump connectivity errors. The errors put stress on the pump’s processor, which causes the infusion pumps to initiate a “watchdog” system error alarm notifying the user of the problem. The affected infusion pump may enter a “fail-safe mode,” which halts all of the pump’s processes including, delivering medicine to the patient. The watchdog system errors may be corrected by “restoring network and server system performance to expected levels.”
Depending on the length of delay, the type of medication infused, the rate and volume of the infusion, the status of the patient, and the patient’s comorbidities, the patient could suffer severe adverse health outcomes or death.
Baxter is currently working on a software upgrade for its Spectrum IQ infusion pumps to address how the Spectrum IQ Infusion Pump responds to an unstable network and server systems by minimizing the stress on the infusion pump’s processing and memory functions. The updated Spectrum IQ Infusion Pump software is expected to be available in the fourth quarter of 2021, and Baxter will schedule the software upgrades with customers. Baxter urges customers to contact Baxter Technical Assistance before making changes to their network or server infrastructure or accessing the Baxter Gateway.
The affected Spectrum IQ Infusion System with Dose IQ Safety Software has a serial number of 3570009.
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