The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)
- Product code: 35700BAX2
- Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9)
- Product Code: 3570009
- Distribution Dates: February 5, 2015 to Present
- Devices Recalled in the U.S.: 277,450
- Date Initiated by Firm: December 29, 2021
The SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) are software-controlled infusion pumps that deliver controlled amounts of fluids such as pharmaceutical drugs, blood, and blood products and other required patient therapies. The fluids are provided through an infusion tubing set into a patient's vein or through other cleared routes of administration. The devices are used in hospitals and other healthcare facilities.
Reason for Recall
Baxter Healthcare is recalling SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events. After an upstream occlusion alarm, failure to fully resolve any upstream occlusion before restarting the infusion can cause the pump to not re-alarm as expected. The pump adjusts occlusion detection after the user acknowledges an upstream occlusion alarm; for the remainder of that infusion, the upstream occlusion alarm will not alarm per its baseline settings. If an occlusion is not fully resolved before restarting the infusion, the pump may not re-alarm as expected and may appear to be infusing normally, though may be infusing below the programmed rate or not infusing at all. Patient harm may occur from interruption in therapy (due to full occlusion) and/or underinfusion (due to partial occlusion).
Use of the affected products may cause serious adverse events, including death.
Baxter has received 51 reports of serious injuries and three reports of patient deaths over five years, potentially associated with this issue.
Who May be Affected
- Health care providers using SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9)
- Patients who require care using SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9)
What to Do
On December 29, 2021, Baxter sent an Urgent Safety Communication to all affected customers with the following instructions:
- Clinicians may continue to use Spectrum V8 and Spectrum IQ infusion pumps by following on-screen instructions, 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 of the Operator’s Manual.
- Be aware that if an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally, though it may be infusing below the programmed rate or not infusing at all.
- If you suspect that you resumed an infusion without clearing an occlusion, stop the infusion by pressing the RUN/STOP key, clear the occlusion, and restart the infusion.
- According to Spectrum’s IFU:
- Reinforce the importance of completely spiking the IV container, removing the blue slide clamp completely from the keyhole, disengaging the blue slide clamp completely from the IV tubing, checking that the IV tubing is clear of any kinks or collapsed sections, ensuring the roller clamp (if present) is released prior to infusion start, and ensuring that rigid and semirigid containers are properly vented. After starting the infusion, verify that drips are flowing in the drip chamber.
- According to Spectrum’s IFU:
- Reinforce that the time to detect an upstream occlusion may be extended if infusing at flow rates below 5 mL/hr. At very low flow rates, it may take several minutes to see drops in the drip chamber.
- When responding to an upstream occlusion alarm, do not press the RUN/STOP key prior to inspecting the IV tubing and resolving any occlusions, as described above. If an upstream occlusion is not fully cleared above the pump and/or within the pumping channel, an upstream occlusion alarm may not reoccur.
- Be aware that an electronic copy of the Operator’s Manual can be accessed at https://service.baxter.com/tsportal/.
- If you received the Safety Communication directly from Baxter, please acknowledge receipt by responding on Baxter’s customer portal at: https://BaxterFieldActionCustomerPortal.onprocess.com/ using the instructions in the letter.
- If you purchased this product from a distributor, please note that responding at the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to the supplier according to their instructions.
- If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them.
- If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please distribute this notification to customers and check the associated box on the customer portal.
Customers with questions about this recall should contact their Baxter sales representative, or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday – Friday, between 7:00 am – 7:00pm Eastern Time.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.