Class 2 Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump

• Date Initiated by Firm: March 02, 2015
• Date Posted: April 16, 2015
• Recall Status: Terminated on May 22, 2018
• Recall Number: Z-1451-2015
• Recall Event ID: 70658
• 510(K)Number: K133801
• Product Classification: Pump, infusion - Product Code FRN
• Product: Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 ; ; The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
• Code Information: Software version 8.0, Product Code 35723V080
• Recalling Firm/ Manufacturer: Baxter Healthcare Corp; 1 Baxter Pkwy # Df6-3w; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
• FDA Determined Cause: Under Investigation by firm
• Action: The firm, Baxter, sent an "Urgent Device Correction" letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.
• Quantity in Commerce: 58 MDLs
• Distribution: Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORPORATION