Z-1665-2018 Class II Terminated

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR 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.

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.

Serial numbers 745365 750241 750330 752814 754975 757930 762405 763117 764490 768855 772652 773031 773134 773520 774413 778845 779430 779822 781545 782706 782985 783185 787001 793146 833195 865842 883498 883854 889556 889775 890230 891398 891421 891647 891689 901881 917897 917963 919594 919736 919837 921078 921819 924734 928406 937123 940345 940860 940949 941786 944619 966019 990542 996435 996823 997156 998126 1011229 1011544 1014955 1027799