United States
Baxter International Inc. announced today it has issued an Urgent Safety Communication to reinforce important safety information regarding upstream occlusion alarms for all Spectrum V8 and Spectrum IQ infusion pumps. Incorrect administration set setup and/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 pump alarm. Spectrum V8 and Spectrum IQ are distributed in the United States, Puerto Rico, Canada and certain Caribbean islands.
Baxter previously communicated this information to customers via an Urgent Safety Communication notification on December 29, 2021. 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.
As described in the Urgent Safety Communication notification, after an upstream occlusion alarm, it is imperative to fully resolve any upstream occlusion before restarting the pump. Failure to do so may cause the pump not to re-alarm as expected, which can lead to interruption in therapy and/or under-infusion. 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.
To date, Baxter has received 51 reports of serious injury and three reports of patient death over five years that may have resulted from incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms. Customers may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions and referencing the Operator’s Manual for infusion setup instructions in the Preparing the Pump and IV Sets and Programming the Pump sections and upstream occlusion alarm troubleshooting in the Alarms section.
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 (if present) is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting an infusion, it is important to verify that drips are flowing in the drip chamber, which may take several minutes when infusing at flow rates below 5 mL/hr. 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.
Product Code: 35700BAX2
Product Description: SIGMA Spectrum Infusion System (V8 Platform)
Unique Device Identifier: GTIN 00085412498683
Serial Number: All
Manufacturing Date: July 1, 2014 – June 8, 2021
Release Date: Feb. 5, 2015 - Present
Released Quantity (Units): 140,674
Product Code: 3570009
Product Description: Spectrum IQ Infusion System with Dose IQ
Unique Device Identifier: Safety Software 00085412610900
Serial Number: All
Manufacturing Date: June 29, 2017 - Present
Release Date: Dec. 6, 2017 - Present
Released Quantity (Units): 175,028
Check the full recall details on
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/baxter-issues-urgent-safety-communication-reinforce-important-safety-information-regarding-upstream
Source: FDA
