SIGMA Spectrum INFUSION PUMP with Master Drug Library

  • Model / Serial
    Contact CDRH for list of affected serial numbers (15,517).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, Puerto Rico and Canada
  • Product Description
    Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique Device Identifier GTIN 00085412091570, Rx ONLY -- Baxter Healthcare Corporation, Medina, NY 14103 --- NOTE: The speakers are a part of the rear case assembly located in the back of the infusion pump. The speaker is intended to generate audible tones during each keystroke, and during alarm conditions. However, some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. Spectrum Infusion Pumps with non-functional speakers will continue to display visual alarm indications, and will otherwise continue to operate as intended.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Natiowide, Puerto Rico and Canada
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
  • Manufacturer
  • Model / Serial
    All serial numbers manufactured from 11/1/2005 to 4/22/2013, with release dates 1/1/2005 and forward.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Product Description
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), infusion pump, 35700BAX and 35700ABB || 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.
  • Manufacturer
  • Model / Serial
    All serial numbers manufactured from7/1/2014 and forward, with release dates 7/1/2014 and forward.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the country of Canada.
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide & Puerto Rico
  • Product Description
    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.
  • Manufacturer
  • Model / Serial
    Serial Numbers 709860 735355 743891 749663 753665 757109 763909 768077 774906 776397 780931 785500 789177 791625 792667 794258 797835 798697 799183 801072 802788 803224 804175 804202 804235 804561 804988 806824 811741 812442 812989 813180 844637 844720 845844 846093 846115 858309 864606 864957 870921 872713 872941 873294 873296 873302 877416 879360 883764 885021 905402 910300 912661 914647 915558 921852 923011 923362 923483 923990 926408 926680 927374 927490 927810 927848 928705 929190 929572 929887 930694 930914 930972 931613 931745 932170 932315 932496 932601 933050 933625 933745 934174 934407 934629 934656 934684 934685 935474 935554 935636 936378 936422 937342 938176 938742 939342 939364 939571 942194 945100 962029 965017 965310 967527 982596 983087 996433 996840 997035 997317 999136 1000594 1006058 1006935 1008672 1011288 1011482 1012217 1012228 1012708 1012883 1013017 1013180 1013371 1013628 1015173 1015537 1015796 1015902 1016229 1016277 1016287 1017064 1017616 1017627
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide & Puerto Rico
  • Product Description
    Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL || 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.
  • Manufacturer
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