Baxter Spectrum Infusion Pumps recall: Reason, affected models, and all you need to know

Baxter International Inc. has issued a nationwide Urgent Medical Device Correction and recall for Baxter Spectrum V8 and Spectrum IQ Infusion Pumps. The pumps that may have recently received a software upgrade are reported to be giving false alarms for upstream occlusions.

Announced on July 28, 2023, the nationwide Urgent Medical Device Correction and recall specifically applies to "SIGMA Spectrum Infusion System (V8 Platform)" and "Spectrum IQ (with Dose IQ Safety Software) Infusion System."

The affected Baxter Spectrum Infusion Pumps are reported to be triggering false alarms for upstream occlusions (Image via Getty Images)

Mostly used in specific medical therapies, the affected Baxter Spectrum Infusion Pumps are software-controlled products that are meant to deliver highly controlled amounts of blood, blood products, pharmaceutical drugs, and other similar fluids to a patient through their veins. The products are used in healthcare facilities and hospitals.

However, the establishment believes that the allegedly faulty software upgrade may cause the infusion pumps to trigger a false upstream occlusion alarm. This could lead to a delay or interruption of therapy for patients.

In such circumstances, a patient who may be on life-sustaining medications could end up experiencing adverse health consequences. Baxter International Inc. has informed the United States Food and Drug Administration of at least three serious cases that may be linked to this problem.

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The recalled Baxter Spectrum Infusion Pumps were only sold in Puerto Rico and the United States

According to the recall notice issued on the United States Food and Drug Administration (FDA) website, the nationwide Urgent Medical Device Correction and recall affects at least two variants of the Baxter Spectrum Infusion Pumps. The recalled products may be in use across Puerto Rico, and the United States.

The recall requires the immediate attention of patients, healthcare providers, and professionals. It applies specifically to "Spectrum IQ Infusion System with Dose IQ Safety Software" and "SIGMA Spectrum Infusion System (V8 Platform)."

Affected Product	Product Code	Software Version
SIGMA Spectrum Infusion System (V8 Platform)	35700BAX2	v8.01.01
Spectrum IQ Infusion System with Dose IQ Safety Software	3570009	v9.02.01

Upgraded to the software versions v9.02.01 and v8.01.01, the affected infusion pumps may pose risks of adverse health issues as they may cause a delay or interruption in therapy for patients using them. The Urgent Medical Device Correction issued by the establishment focuses on fixing this problem by reverting the software on the concerned pumps to their previous versions.

Baxter has already started contacting all known customers of the affected Baxter Spectrum Infusion Pumps to schedule the necessary software reversions. Until the software reversions have been completed, customers are advised to use the Spectrum IQ and Spectrum V8 infusion pumps by following the on-screen instructions.

The recalled Baxter Spectrum Infusion Pumps will be fixed with software reversions (Image via Getty Images)

Individuals can also refer to the Alarms section of the Operator's Manual for the same. Customers who may still find it difficult to resolve the issue regarding the upstream occlusion alarms are advised to unload and reload the set. Though the Baxter Spectrum Infusion Pumps were sold across certain Caribbean Islands, Puerto Rico, the United States, and Canada, the recalled products were only sold in and around Puerto Rico and the United States.

Individuals who may have concerns about the affected infusion pumps can contact the company's technical assistance team at 800-356-3454. The establishment can be reached between 6:00 am and 6:00 pm Central Time, from Monday to Friday.