Medical Device Correction: Baxter Sigma Spectrum

Medical Device Correction: Baxter Sigma Spectrum

Dear USME Partners, 

A software error may occur following the completion of a secondary infusion, during the programming of a repeat of that secondary infusion. When the user attempts to repeat the programming of a secondary infusion with a concentration string longer than 19 characters (e.g., 2000 mUnits/2000 mL), the pump will display “Improper Shutdown” and “System Error 101” messages. The user must then power cycle the device and reprogram both the primary and secondary infusions, as the previously set infusion parameters will have been cleared.

This software error occurs during the programming of a Spectrum pump and does not occur during infusion. To date, there have been no reports of adverse events or patient injury associated with this issue.

  1. Operators may continue to use the Spectrum infusion pumps until the correction is completed.
  2. The software upgrade for Spectrum IQ is available, and will be implemented upon next service, or a local Baxter service representative will contact you facility to schedule the software upgrade. When the software upgrades for V8 and V6 pumps are available, they will be implemented upon next service, or a local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade.

If you have additional questions or experience quality problems, please contact Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.

Should you have any questions, please reach out to the US Med-Equip Quality Assurance Team at QA@usmedequip.com .

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We are committed to your patients as much as you are — it’s rooted in our daily actions — so we understand the importance of safely servicing recalls promptly.

About US Med-Equip

US Med-Equip (USME) partners with top hospitals across the nation to provide the highest quality movable medical equipment for patients in their care. USME, an Inc. 5000 Fastest Growing company, supplies quality-certified equipment rented, sold, maintained and managed using the latest technology to help healthcare providers focus on their patients’ healing.