—#201609

Product

The Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K230041
Affected lot / code info: UDI/DI 00085412610900, Software Version v9.02.01, All Serial Numbers

Why it was recalled

A medical device correction is being issued for SIGMA Spectrum Infusion System (V8 Platform) and Spectrum IQ Infusion System with Dose IQ Safety Software infusion pumps due to an increase in reported false upstream occlusion alarms following upgrades to software versions v8.01.01 and v9.02.01.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Customers were contacted via phone and email beginning on June 2, 2023. An Urgent Medical Device communication was sent to all affected customers on June 15, 2023, via U.S.P.S., first class mail. The notice explained the problem, the risk involved, and requested the following: "Actions to be taken by Customers: 1. Operators may continue to use Spectrum V8 and Spectrum IQ pumps by following on-screen instructions, or the 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. An electronic copy of the Operator s Manual can be accessed at https://service.baxter.com/tsportal/. Please note that false upstream occlusion alarms can occur at a higher rate until the software reversion is completed. If you are unable to resolve an upstream occlusion alarm, unload and reload the set. 2. A Baxter representative will contact your facility to determine the correction plan and schedule the software reversion. The representative will work with you to determine a list of affected serial numbers at your facility. Please note you will be receiving this software reversion from Baxter at no charge." "Further information and support: If you have additional questions or experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-356-3454 (choose option 3) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time."

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2023-06-15
Posted by FDA: 2023-07-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201609. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.