Class 2 Device Recall Sigma Spectrum Infusion Pump with master Drug Library Version 6.

• Date Initiated by Firm: April 03, 2018
• Date Posted: May 04, 2018
• Recall Status: Terminated on February 14, 2020
• Recall Number: Z-1663-2018
• Recall Event ID: 79815
• 510(K)Number: K042121
• Product Classification: Pump, infusion - Product Code FRN
• Product: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 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 includes pharmaceutical drugs, blood, blood products and mixture if required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, intrathecal, epidural or irrigation of fluids. Spectrum infusion pump is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by user. The 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.
• Code Information: Serial Numbers 400792 402108 718349 719336 720207 724491 724820 725718 725967 728874 728899 732513 734021 734895 736505 737537 743970 745479 745645 746786 746958 749627 753240 755355 755385 757870 759563 762135 763024 765577 766622 769032 769488 778233 782558 786281 786340 786870 787341 792737 795834 796263 800153 800502 801288 802530 805121 805471 805801 806919 807211 813520 814347 814382 815314 816930 820150 820359 822492 825071 825229 825451 826055 826627 828591 828705 829397 830727 831128 831212 831302 831547 831565 832787 833304 834044 834712 835095 835382 835391 836112 836152 837841 838434 838774 839173 840083 840954 842022 842183 845112 845156 847861 847901 848231 848841 849061 849254 849944 850141 850340 851569 852394 852641 852892 853302 853382 853786 854089 855099 855122 855273 856674 856866 859951 860191 860303 862042 863777 865269 865418 865580 865720 866428 867262 868826 869057 869182 869234 869974 871376 871764 871877 872071 872863 873254 873259 874491 878338 879016 880653 880795 880832 880843 880964 881244 881617 881705 881777 881918 882789 883187 883398 883416 883633 884068 884237 886454 887689 889858 890428 890758 894234 894348 894617 895900 898761 901813 904457 905119 906737 907869 908249 909244 912418 912732 915132 915423 916017 919364 920356 925142 927197 928329 929730 930711 936707 938183 939798 940023 940386 940611 942273 943001 943885 943973 944249 946995 953811 954927 957053 959168 959347 960426 962828 963374 963861 964644 965116 973423 974215 977054 977058 978363 982851 988268 989495 990271 990388 991778 992782 993040 993151 993935 994571 994836 995376 998593 1000562 1000614 1000881 1001843 1002586 1013602
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 711 Park Ave; Medina NY 14103-1036
• For Additional Information Contact: 800-422-9837
• Manufacturer Reason for Recall: Service technician improperly documented final release testing on product, indicating that the full battery of release tests were performed when, in fact, several tests were omitted. he omitted tests include air-in-line detection at 400ml/hr and 800ml/hr and verification of upstream occlusion detection at 800ml/hr. Improper detection of air-in-line or upstream occlusion may result in serious adverse health consequences.
• FDA Determined Cause: Employee error
• Action: On 4/3/18, Baxter HealthCare Corporation mailed URGENT MEDICAL DEVICE CORRECTION notices and Reply Forms to customers via first class mail. Actions to be Taken by Customers: 1. Locate and discontinue use of all affected pumps at your facility. 2. Return the device to Baxter for testing. To arrange for return of affected devices, contact Baxter 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 via email to fca@baxter.com even if you do not have inventory. 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.
• Quantity in Commerce: 444 units in total
• Distribution: US Nationwide & Puerto Rico
• 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 = SIGMA INTL.