Device manufacturer Baxter released an Urgent Safety Communication last week about the company's Spectrum V8 and Spectrum IQ infusion pumps, citing potential compromised medication delivery caused by upstream occlusions — partial or full blockage — of the device.
This is the second such alert from the company. Baxter initially called attention to the problem in a December 29, 2021, Urgent Safety Communication.
As of February 17, the company received a total of 51 reports of serious injury and three reports of patient deaths over 5 years that were potentially associated with the setup or incomplete resolution of upstream occlusion alarms.
"Customers notified Baxter that the pump was not delivering medication at the programmed rate displayed on the screen, and in some cases was not alarming for upstream occlusions," the US Food and Drug Administration noted when sharing the second Urgent Safety Communication. Baxter reissued the safety warning voluntarily.
Healthcare professionals can continue to use the Spectrum V8 and Spectrum IQ infusion pumps, taking care to fully clear any upstream occlusion before restarting the pump. Failure to do so could result in an alarm not sounding during subsequent instances of underinfusion or blocked infusion of medication.
"The potential harm to the patient depends on several factors such as length of therapy delay, medication being infused, volume and rate of infusion, and the patient's underlying status and comorbidities," the company stated in the Urgent Safety Communication.
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.
US FDA Company Announcement, February 18, 2022
Baxter Urgent Safety Communication, December 29, 2021
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Cite this: Safety Alert Reissued for Baxter IV Infusion Pumps - Medscape - Feb 23, 2022.