Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6 and Version 8)

• Date Initiated by Firm: May 08, 2018
• Create Date: June 07, 2018
• Recall Status: Terminated on April 08, 2019
• Recall Number: Z-2113-2018
• Recall Event ID: 80014
• 510(K)Number: K133801
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2 Product Usage: The Baxter SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixture of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. Spectrum Infusion Pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and Spectrum with Master Drug Library is suitable for many user facility applications such as but not limited to hospitals, outpatient care areas, homecare and ambulatory care services. Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to the physicians directive.
• Code Information: All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 711 Park Ave; Medina NY 14103-1036
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: The firm will be updating the Instructions for Use for the product. Current IFUs instruct users to lower the primary bag 20 inches below the secondary bag using a hanger when performing a secondary infusion. However, the firm supplies 12.5-inch hangers with the Baxter disposable secondary sets.
• FDA Determined Cause: Other
• Action: On May 8, 2018, Baxter issued a Medical Device Correction letter to its customers. Customers were advised of the issue and instructed to do the following: 1. The SIGMA SPECTRUM Infusion Pumps can continue to be safely used with the Baxter-provided 12.5-inch hanger. 2. The updated Instructions for Use will be made available by May 31, 2018. At that time, you may access the updated IFU online at the Baxter Global Technical E-Service Center at URL: https://service.baxter.com/tsportal/#/login. For additional questions and concerns about this issue please contact Baxter Healthcare Medina at 800-356-3454, Option 1, between the hours of 7:00 am and 7:00 pm Eastern Time. 3. If you purchased this product directly from Baxter, complete the enclosed Baxter 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, even if you do not have any inventory. Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you purchased this product form a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 5. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. 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 Medical Device Correction in accordance with your customary procedures.
• Quantity in Commerce: 122889
• Distribution: Worldwide Distribution - US Nationwide and the 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