Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Recalls, Market Withdrawals, & Safety Alerts

Recalls, Market Withdrawals, & Safety Alerts

                        Recall Resources


                        Enforcement Reports
          Industry Guidance For Recalls
          Major Product Recalls
          Archive for Recalls, Market Withdrawals & Safety Alerts Home
          Safety
          Recalls, Market Withdrawals, & Safety Alerts
          Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)Recalls, Market Withdrawals, & Safety Alerts COMPANY ANNOUNCEMENT
    
  
  
  Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

  
    
        When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
      Read Announcement
  
  
  Share
    Post
    Linkedin

    Email
    PrintSummary

  Company Announcement Date:
             October 28, 2020

                          FDA Publish Date: 
               October 29, 2020
                                    Product Type: 
              Medical Devices
                          Reason for Announcement:
              Recall Reason Description
              Deviations from the specified cleaning methods may impair infusion pump

            Company Name: 
              Baxter International Inc.

            Brand Name:
              Brand Name(s)
          Sigma Spectrum

            Product Description:
              Product Description
          Infusion Pumps   
Company Announcement



Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all **Spectrum** infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may impair infusion pump functionality and performance. Baxter previously communicated this information to customers directly in a Safety Alert on April 1, 2020 and subsequently via an Urgent Device Correction notification on August 28, 2020.

Deviations from the cleaning methods described in product-specific Operator’s Manuals may lead to residue buildup or corrosion of the electrical pins (e.g. depressed pins) on the infusion pump rear case and battery electrical contacts. This could result in notifications that the user should check the battery, or that batteries are not charging or holding their charge. If a device has residue buildup or corrosion, and is running solely on battery power, the pump may shut down without alarming or alerting the user. An undetected or abrupt discontinuation in medication delivery may lead to a delay or interruption of intended treatment. Depending on various factors, including the medication being infused, the volume and rate of the infusion, the route of administration, and patient status and comorbidities, this could result in serious adverse health consequences or death. **To date, Baxter has received 16 reports of serious injuries that may have resulted from improper cleaning practice-related residue buildup and/or corrosion.**

In addition to adhering to the cleaning instructions provided in the Operator’s Manuals for the products listed below, Baxter is instructing customers to assess the rear case electrical pins and battery electrical contacts for residue buildup or corrosion and depressed pins. Baxter is also recommending to have backup devices readily available when infusing critical medications. Additionally, the infusion pumps should be connected to AC power when possible to prevent battery depletion. Finally, Baxter will be clarifying the Instructions for Use (IFU) to recommend a routine inspection to identify signs of residue buildup, corrosion and depressed pins. Once completed, Baxter will issue a written notification to inform customers of the availability of the updated IFU, which will be accessible in Baxter’s Global Technical E-Service Center: https://service.baxter.com.

**Product Code**
			**Product Description**
			**Serial Number**35700BAX
			SIGMA SPECTRUM Infusion System
			(V6 Platform)
			All35700ABB35700BAX2
			SIGMA SPECTRUM Infusion System
			(V8 Platform)3570009
			Spectrum IQ Infusion System with Dose
			IQ Safety Software

Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Any adverse events experienced with the use of these products may be reported using one of the following options:

Calling Baxter Product Surveillance at 800-437-5176 Monday through Friday between 8 a.m. and 5 p.m. Central Time
	Emailing Baxter at: corporate_product_complaints_round_lake@baxter.com
	Complete and submit the report Online
	Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178Baxter is voluntarily issuing this Urgent Device Correction with the knowledge of the U.S. Food and Drug Administration.

**About Baxter**

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.





Company Contact Information
  
  
    Consumers:       

                 Baxter Technical Assistance
        
                 800-356-3454, Choose Option 1
    Media:
      
              Bess Featherstone
      
              224-948-5353
      
              media@baxter.com

                                                                                  Content current as of:
      10/29/2020
               
             
Regulated Product(s)
		 Medical Devices   
        
        Follow FDA
            Follow@US_FDAon X
              FollowFDAon Facebook
              Follow@FDArecallson X
              Recent Recalled Product Photos on FDA's Flickr PhotostreamMore Recalls, Market 
    Withdrawals, & 
    Safety Alerts

        Recalls, Market Withdrawals, & Safety Alerts

          
                        Recall Resources


                        Enforcement Reports
          Industry Guidance For Recalls
          Major Product Recalls
          Archive for Recalls, Market Withdrawals & Safety Alerts
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop