Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump

• Date Initiated by Firm: June 21, 2018
• Create Date: May 02, 2019
• Recall Status: Terminated on May 23, 2019
• Recall Number: Z-1248-2019
• Recall Event ID: 80355
• 510(K)Number: K133801
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX - 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 physician s directive.
• Code Information: 414100 414670 433162 710740 717215 719988 720854 721951 722543 722933 725642 732556 734067 749265 749642 749657 751266 754953 755565 756625 756644 758179 759427 760110 760525 761003 762192 763831 764008 772521 772551 772633 776752 777472 777487 777680 777749 778181 778251 778579 779966 780547 780718 780817 782396 782707 782811 783349 783493 786411 788383 788710 789338 789840 790679 792271 792369 794031 794748 799042 800030 801760 801943 803923 804476 804682 806531 813188 814142 816514 820804 821669 823024 823027 824627 824732 825824 826787 829610 831764 832868 834783 835743 836236 837842 839622 840360 840428 841012 841184 841214 841342 842898 843667 843683 847890 848208 848231 848488 848787 849440 849507 849907 850267 850852 851179 851268 852222 853708 854814 855334 855504 855857 856876 856969 858560 860351 861014 861464 861482 863379 868085 870747 871288 874631 875102 875155 878163 878164 881784 884140 892778 894505 899196 909742 910678 918775 921328 923433 937769 942978 944660 945944 949235 953654 954700 954902 963058 970869 974360 976700 977543 981313 983629 984364 988111 988760 995070
• 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 flow rate test verification was not properly executed for certain Sigma Spectrum infusion pumps prior to release. The testing was performed for less than the required minimum run time. Improperly performed flow rate testing may not identify issues with pumps that could cause inaccuracies in flow rates which, in turn, could lead to over- or under- infusion. Potential risk to the patient depends on a number of factors including treatment and patient comorbidities. Depending on these factors, the patient could experience serious adverse health consequences.
• FDA Determined Cause: Process control
• Action: On June 22, 2018, the firm notified customers by sending out an Urgent Medical Device Correction letter via USPS first class mail. Users were provided with affected serial numbers specific to their site, and informed that flow rate testing had not been properly executed on the identified devices. The firm is requesting the return of all affected devices to ensure proper testing is performed. ***Actions to be taken by Customers*** 1. Locate all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter Healthcare Medina at 800-356-3454 between the hours of 7:00 am and 7:00 pm Eastern Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, serial number, and quantity of devices to be returned ready when calling. 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 customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. 4. If you purchased this product from 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 Urgent Medical Device Correction in accordance with your customary procedures. If you have additional questions, please contact your Baxter sales rep
• Quantity in Commerce: 158
• Distribution: US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, FA, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, VT, WA, and WI.
• 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