Baxter Warns of Spectrum Infusion Pump Problems

Dozens of serious injuries and at least three deaths may be linked to problems with Baxter Spectrum infusion pumps, where the alarm may malfunction.

The U.S. Food and Drug Administration posed a safety communication late last week, warning about issues with more than 315,000 Baxter Sigma Spectrum V8 and Spectrum IQ infusion pumps, which may result in a reduced delivery or non-delivery of medication if there is an incorrect administration set setup or incomplete resolution of an upstream occlusion alarm.

The action does not constitute a Baxter infusion pump recall, and medical providers can continue to use the Spectrum V8 and Spectrum IQ pumps. However, in the event of an upstream occlusion alarm, the manufacturer indicates that it is imperative to resolve the alarm before restarting the pump, which may cause the device not to issue another alarm as expected, leading to interruption in therapy or under-infusion.

There have been at least 51 reports of serious injury received from consumers and three reports of patient death over 5 years, according to Baxter. These injuries have been linked to incorrect administration, set up, and/or incomplete resolution of upstream occlusion alarms.

The safety warning was prompted after customers notified the company the pump was not providing medication at the programmed rate displayed on the screen. In some cases, the device was not issuing an alarm for upstream occlusions.

Incorrect setup or incomplete resolution can lead to reduced delivery or non-delivery of medication. In some case, this can occur without alerting the user via the pump alarm.

Once an upstream occlusion alarm sounds, it is necessary to resolve any upstream occlusion before restarting the pump. Failing to resolve the alarm can lead to the pump not issuing another alarm when expected, which can lead to interruption of therapy and/or under-infusion of the medication being issued.

Failure for any of these steps to occur can lead to harm to the patient and depends on the how long a delay in therapy has occurred, the medication being infused, volume and rate of infusion and the patient’s underlying condition and severity. Patients can continue to use the Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions and referencing the Operators manual for setup instructions.

To help prevent upstream occlusions, it is important to completely spike the IV container, remove the blue slide clamp completely from the keyhole, disengage the blue slide clamp completely from the IV tubing, check that the IV tubing is clear of any kinks or collapsed sections, ensure the roller clamp is related prior to infusion start, and ensure that rigid and semirigid containers are properly vented, Baxter advises.

After starting an infusion, it is necessary to verify that drips are flowing in the drip chamber and may take several minutes when infusing at flow rates below 5 mL/hr.

If an upstream occlusion continues after the RUN/STOP key is pressed, the pump may appear to be infusing normally, but may be infusing below the programmed rate or not infusing at all, which can lead to harm to a patient.  If a doctor suspects that they resumed the infusion without clearing an occlusion they should stop the infusion by pressing the RUN/STOP key to clear the occlusion and restart the infusion.

Baxter plans to issue a follow-up letter to customers to communicate further details concerning the safety warning and steps the company will be taking to resolve the issue.

Spectrum V8 and Spectrum IQ infusion pumps are distributed in the United States, Puerto Rico, Canada, and certain Caribbean Islands. The safety warning involves these models:

• 35700 BAX2 SIGMA Spectrum Infusion Systems with device identifier GTIN00085412498683 manufactured July 1, 2014 – June 8, 20221.
• 3570009 Spectrum IQ Infusion System with Dose IQ Safety Software with device identifier 00085412610900 manufactured June 29, 2017-present.

Customers with questions about the safety warning can contact Baxter at 800-356-3454. Customers who have experienced adverse events or side effects involving one of these products should report the issue to the FDA through the MedWatch Adverse Event Reporting Program.

This is not the first time Baxter has been affected by safety issues regarding its Spectrum infusion drug pumps. In 2020, more than a half million Sigma Spectrum infusion pumps were recalled due to corrosion and cleaning problems.

In late 2020, the company issued another safety warning regarding Sigma Spectrum infusion pumps and concerns about cleaning practices. Last year, the Spectrum IQ infusion pump was recalled following issues with software defects.