FDA Reports Safety Announcement for Spectrum V8 and Spectrum IQ Infusion Pumps

In the safety communication, Baxter advised that incorrect administration set up or incomplete resolution of upstream occlusion alarms may result in reduced delivery or non-delivery of medication, in some cases without alerting the user via the pump alarm. Baxter’s February 2022 announcement reinforced its previous report to consumers in December 2021. 

The following infusion pumps distributed in the United States, Puerto Rico, Canada, and certain Caribbean Islands are affected:

Product Code	Product Description	Unique Device Identifier	Serial Number	Manufacturing Date	Release Date	Released Quantity (Units)
35700BAX2	SIGMA Spectrum Infusion System (V8 Platform)	GTIN 00085412498683	All	July 1, 2014–June 8, 2021	February 5, 2015–Present	140,674
3570009	Spectrum IQ Infusion System with Dose IQ Safety Software	00085412610900	All	June 29, 2017–Present	December 6, 2017–Present	175,028

Baxter said consumers reported 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. Baxter said it is imperative to fully resolve any upstream occlusion before restarting the pump, and failure to do so may cause the pump not to re-alarm as expected, which can lead to therapy interruptions or underinfusion. The potential patient harm depends on length of therapy delay, medication being infused, volume and rate of infusion, and patient status and comorbidities. 

To date, Baxter has received 51 reports of serious injury and 3 reports of patient death over five years that may have resulted from incorrect administration setup or incomplete resolution of upstream occlusion alarms.

FDA said that customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following the on-screen instructions and referencing the operator’s manual for infusion setup instructions. To prevent upstream occlusions, 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 kinks or collapsed sections, ensure the roller clamp (if present) is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting an infusion, verify that drips are flowing in the drip chamber, which may take several minutes when infusing at flow rates below 5 ml per hour. If an upstream occlusion remains 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. If a clinician suspects that they resumed an infusion without clearing an occlusion, they should stop the infusion by pressing the RUN/STOP key, clear the occlusion, and restart the infusion.

Patients with questions can contact Baxter Technical Assistance at 800-356-3454, option 1, Monday–Friday, from 6 am–6 pm CT.

Healthcare professionals and consumers should report any adverse reactions of quality problems they experienced using the products to MedWatch (FDA’s Safety Information and Adverse Event Reporting Program) or to Baxter at 800-437-5176, Monday–Friday, from 8 am–5 pm CT, and corporate_product_complaints_round_lake@baxter.com.