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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall Sigma Spectrum Infusion Pump with master Drug Library Version 6. see related information
Date Initiated by Firm April 03, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on February 14, 2020
Recall Number Z-1666-2018
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) 35700BAXRP

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 792177 795979 802612 805938 807209 813365 813367 871387 922364 935968 962932 963087  
Recalling Firm/
Baxter Healthcare Corporation
711 Park Ave
Medina NY 14103-1036
For Additional Information Contact
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 2
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.