FDA MedWatch: Early Alert- Infusion Pump Software Issue from Baxter

FDA MedWatch Early Alert

Infusion Pump Software Issue from Baxter

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available. 

Affected Product

Spectrum V6 infusion pump startup screen                     Spectrum V8 infusion pump startup screen

The FDA is aware that Baxter has issued a letter to affected customers recommending certain Spectrum Infusion Pumps be removed from where they are used or sold:

Affected Serial Numbers

Affected Serial Numbers

What to Do

Identify affected Spectrum pumps and remove them from service. Check the software version installed on the pump and contact Baxter to schedule service if required. 

• On June 20, Baxter sent all affected customers a letter recommending the following actions:
  
  • Immediately locate Spectrum pumps with the affected serial numbers and remove them from service. The product code and serial number can be found on the bottom of the infusion pump.  
  • Check and record the software version installed on the pump. The software on a V6 pump should begin with the number 6 and the software on a V8 pump should begin with the number 8. The software version is located on the startup screen upon powering up the pump as pictured above.  Additionally, the software version is indicated in the pump menu which can be accessed by following the steps below.  
    
    • For V6: From the Pump Information screen, press the ‘sw info’ soft key to display the software version screen.
    • For V8: From the Select Care Area screen, press the ‘options menu’ soft key. Select ‘User Options’ and press OK. Select ‘View Information’ and press OK. Select ‘Pump Information’ and press OK to display the Pump Info screen.
  • Contact Baxter to confirm the software version on the affected pumps and to schedule service if required. Baxter Global Technical Services can be reached at 800-843-7867 Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
  • If you received this communication directly from Baxter, acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification.
  • If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions.
  • Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product.
  • If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Recall in accordance with your customary procedures and check the associated box on the customer portal.
• Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. 

Rason for Alert

Baxter stated that certain Spectrum infusion pumps may have an incorrect version of software. A software version intended for Spectrum V8 may have been installed on the affected Spectrum V6 pumps, and a software version intended for Spectrum V6 may have been installed on the affected Spectrum V8 pumps. Spectrum software is designed for the pumping mechanism setup specific to each pump platform. The V8 software installed in a Spectrum V6 pump, or vice versa, may cause an inaccurate flow rate of overinfusion or underinfusion, especially over a long run time. Additionally, the V6 and V8 designs include many differences in the clinical workflow and user interface. The appearance of the menus and the requested inputs from the pump are different between the two platforms. If a user who was trained and experienced on a V6 pump was presented with a V6 pump with V8 software, or vice versa, they may experience confusion and delay during use or may accidentally mis-program the infusion.  

This could result in a delay or interruption of therapy, underinfusion, or overinfusion. The issues described above may lead to serious adverse health consequences such as drug toxicity, overdose, fluid overload, electrolyte imbalances, and delayed or subtherapeutic drug levels causing ineffective treatments. The severity and nature of these outcomes include serious injury and death, and are dependent on the type of medication, fluid, or infusate being delivered and the clinical condition of the patient, with high-risk populations being particularly vulnerable. 

As of June 12, Baxter has reported no serious injuries or deaths associated with this issue. 

Device Use

Spectrum infusion pumps are intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified health care professional. 

Contact Information  

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Baxter at corporate_product_complaints_round_lake@baxter.com or 800-843-7867.

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.

• How do I recognize a UDI on a label?
• AccessGUDID database - Identify Your Medical Device
• Benefits of a UDI System  

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.