Sigma Spectrum Infusion System Master Drug Library User Manual

Dec 07, 2016  The safety management system includes an infusion analytics application, which creates infusion data analyses and graphical reporting to help identify pump programming errors. Existing Sigma Spectrum tools include the Master Drug Library, which allow users to create customized lists of medications within appropriate dose ranges. Baxter added. Efficient, small pump design The SIGMA Spectrum Infusion System reduces errors in programming IV infusion. The SIGMA Spectrum is easy to use with automatic start-up of the Master Drug Library (MDL) and capability to integrate infusion data into the Electronic Medical Record (EMR). Apr 16, 2013 Subject: SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) Dear Customer, On April 1, 2013, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Baxter Healthcare Corporation regarding the 510(k) clearance status of modifications made to the SIGMA Spectrum Infusion Pump with MDL since its initial clearance.

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DESCRIPTION

Designed with you and your patients in mind.

The SIGMA Spectrum Infusion System has features that help reduce errors when programming an IV infusion. For example, the SIGMA Spectrum Infusion System automatically defaults to using the drug safety library at the initial start of the system. Small, lightweight and easy-to-use, the SIGMA Spectrum Infusion System also offers wireless connectivity to integrate data into a hospital’s EMR system and facilitate the transfer of data to and from the system for updating drug libraries as well as for continuous quality improvement reports.
Rx Only. For safe and proper use of this device, refer to the complete instructions in the Operator’s Manual.

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2

Replies
-TriumphMED
3 months ago
3 months agoUnder Infusing
When testing the Sigma Spectrum we continually get under infusion. In some cases the accuracy is -10%. When sending the pump in to Manufacturer they claim the pump is only under infusing at -4%. We had this happened to many Sigma Spectrum Pumps. We use certified Flowtrax II system also a certified scale to confirm. We also follow the manufacturers recommendation on test parameters and setup. Anyone else having this issue with these pumps? We do not have any issue testing any other brand of pumps including the older Baxter 6201's.Reply
-Chris S
7 months ago
7 months agoError 320 (Latch Switch Error)
Error 320 can occasionally be caused by dirt/debris on either latch switch. Try cleaning with distilled water and a cotton swab before resigning to send the device in for repair.Reply

0

Replies
-Chris S
a year ago
a year agoNuisance Upstream Occlusion Troubleshooting
Nuisance upstream occlusion alarms are typically caused by deformed sections of IV set tubing or by Micro-bubbles collecting in front of the upstream sensor. Here are some tips for troubleshooting upstream occlusion alarms that can not be reproduced by bench testing:1) Keep tubing channel clean and dry. 2)Use only compatible IV sets. 3) Warm fluids to room temp prior to IV Set priming. 4) Fill IV set drip chambers 1/2 to 3/4 full. 5) Invert IV bags to mix (do not shake). 6) Avoid excessive lengths of tubing above the pump. 7) Check all set connections, vents, and filters. 8) Do not load deformed tubing sections into channel. 9) Do not use sets beyond recommended interval. If a Nuisance Alarm is suspected - Check for micro-bubbles and/or deformed tubing in front of the Upstream Sensor. Load a fresh section of the IV set into the tubing channel if bubbles are present.Reply
DOCUMENTS / MANUALSView All






VIDEOS

Baxter's SIGMA Spectrum Infusi...

Baxter's SIGMA Spectrum Infusion System Receives Best in KLAS A...

Sigma Spectrum...

This video is a step-by-step demonstration on how to operate the Sigma Spectrum infusion pump, fo...

FEATURES

  • Multiple Prevention Systems > Configurable dose error reduction software > Single step titration limit > Check flow at start of infusion > Secondary container infusion check
  • Comprehensive log software to create CQI reports; Rapid, Intuitive Work-flow > Easy to set-up and program safely > Bright, easy to read color display > Use of Baxter's standard IV administration sets > Quick drug find library search
  • Economic Value > Utilizes Baxter's standard IV administration sets to help reduce set up time and waste > Facilitates easy training of staff

SPECIFICATIONS

Flow Rate Range0.5 to 999 ml/h
Infusion Pump TypeGeneral-Purpose
KVO Range0.5 to 50 ml/h
Volume to be Infused0.1 to 9999 ml
Height5.8 in
Length 2.5 in
Weight2.5 lbs
Width4.2 in
NEWSView All
How Do You Know Which Infusion Pump is Best?

Infusion pumps are invasive pieces of medical equipment that work to save lives through preventing dehydration, and also aid in the continual release of medication.

Acquisition Enhances Baxter’s Position as a Global Provider of...

Baxter International Inc. announced today it has exercised its option and completed the purchase of SIGMA International General Medical Apparatus, LLC. by acquiring the remaining 60 percent of the company for $90 million.

BAXTER’S SIGMA SPECTRUM INFUSION SYSTEM RECEIVES BEST IN KLAS AWARD...User

Baxter International Inc. announced its SIGMA Spectrum Infusion System has received the 'Best in KLAS' award for the second consecutive time at the 2012 Best in KLAS Awards: Medical Equipment & Infrastructure report.

FDA AlertsView All
ManualClass 1 Recall: Baxter Healthcare Corporation, Sigma Spectrum...

Recall Class:Class I Date Recall Initiated:February 7, 2014 Products: Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB Affected products were manufactured from July 1, 2005

Expanded Class 1 Recall:SIGMA Spectrum Infusion Pump Model 35700

Based on additional analyses since the initial recall, SIGMA expanded their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above. These units may fail suddenly

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Manual

Sigma Spectrum Infusion System Master Drug Library User Manual Online

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Sigma Spectrum Infusion System Master Drug Library User Manual 2016

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Class 2 Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump
Date Initiated by FirmMarch 02, 2015
Date PostedApril 16, 2015
Recall Status1Terminated 3 on May 22, 2018
Z-1451-2015
Recall Event ID70658
K133801
Pump, infusion - Product CodeFRN
ProductMaster Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2
The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Code InformationSoftware version 8.0, Product Code 35723V080
Recalling Firm/
Manufacturer
Baxter Healthcare Corp
1 Baxter Pkwy # Df6-3w
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
800-422-9837
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured. The discrepancy may cause therapy delay or unintended rate of delivery.
Under Investigation by firm
The firm, Baxter, sent an 'Urgent Device Correction' letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed 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. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.
58 MDLs
Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
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) Database510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORPORATION