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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library

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  Class 2 Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library see related information
Date Initiated by Firm January 26, 2017
Create Date October 02, 2017
Recall Status1 Terminated 3 on May 24, 2018
Recall Number Z-1693-2017
Recall Event ID 76364
510(K)Number K133801  
Product Classification Pump, infusion - Product Code FRN
Product Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
Code Information 14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
711 Park Ave
Medina NY 14103-1036
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
FDA Determined
Cause 2		 Process design
Action URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.
Quantity in Commerce Domestic: 14,175 units; Canada: 187 units
Distribution Natiowide, Puerto Rico and Canada
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 = BAXTER HEALTHCARE CORPORATION
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