Class 1 Device Recall Baxter SIGMA Spectrum

• Date Initiated by Firm: December 29, 2021
• Date Posted: January 29, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0530-2022
• Recall Event ID: 89017
• 510(K)Number: K133801
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.
• Code Information: All serial numbers, GTIN 00085412498683.
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: There is the potential for reduced or non-delivery of medication, in some cases without alerting the user via pump alarm. This may occur as a result of incorrect administration set setup and/or incomplete resolution of upstream occlusion alarms when using Spectrum V8 and Spectrum IQ infusion pumps.
• FDA Determined Cause: Device Design
• Action: The firm sent URGENT SAFETY COMMUNICATION letters on 12/29/2021 via first class mail, addressed to Directors of Biomedical Engineering, Risk Management, Nursing, and Nurse Educators. The letter described the problem, the affected product (Spectrum V8 and Spectrum IQ infusion pumps), hazard involved, and the actions to be taken by customers. Acknowledge receipt on customer portal https://BaxterFieldActionCustomerPortal.onprocess.com/. Follow on-screen instructions, 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. Upon an upstream occlusion alarm, do not press the RUN/STOP key prior to inspecting the IV tubing and resolving any occlusions. If an upstream occlusion remains after the RUN/STOP key is pressed, the pump may appear to be infusing normally, and may be infusing below the programmed rate or not at all. If you may have resumed an infusion without clearing an occlusion, stop the infusion: press the RUN/STOP key, clear the occlusion, and restart the infusion. Per the IFU: It is important to completely spike the IV container, remove the blue slide clamp completely from the keyhole, disengage the blue slide clamp completely from the IV tubing, check that the IV tubing is clear of any kinks or collapsed sections, ensure the roller clamp is released prior to infusion start, and ensure that rigid and semirigid containers are properly vented. After starting the infusion, verify that drips are flowing in the drip chamber. If an upstream occlusion is not fully cleared above the pump and/or within the pumping channel, an upstream occlusion alarm may not reoccur. **On 1/19/2022, the firm reported they plan to issue a follow-up communication approximately March 2022 to customers once the IFU has been updated and will include information regarding upcoming software updates.
• Quantity in Commerce: 140,674 units
• Distribution: Worldwide Distribution. US nationwide Puerto Rico and St. Thomas. There was government/military distribution. Countries of Canada, Bahamas, Barbados, Bermuda, Guyana, Jamaica, and Trinidad and Tobago.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN