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U.S. Department of Health and Human Services

Class 2 Device Recall SIGMA SPECTRUM Infusion Pump with Master Drug Library

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 Class 2 Recall
SIGMA SPECTRUM Infusion Pump with Master Drug Library
see related information
Date Posted November 08, 2013
Recall Status1 Open
Recall Number Z-0197-2014
Recall Event ID 66120
Premarket Notification
510(K) Number
K042121 
Product Classification Pump, Infusion - Product Code FRN
Product SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Code Information Product Code: 35700BAX, 35700ABB Serial Numbers: All
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
Manufacturer Reason
for Recall
Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Drug Library due to reports of upstream occlusion alarms and air-in-line alarms occurring during infusions.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action On June 10, 2013 Baxter Healthcare Corporation issued an Urgent Device Correction for the SIGMA SPECTRUM Infusion Pump with Master Drug Library. The notices were dated June 5, 2013 and were distributed via first class mail. Until further information is provided, users should continue to follow the SIGMA SPECTRUM Infusion Pump Operator's Manual, which identifies a number of environmental and clinical usage factors that contribute to upstream occlusion and air-in-line alarms. For high-risk patients, consider having additional devices as backup. If the biomedical engineer finds that the sensor is not functioning properly, contact Baxter Healthcare at 800-356-3454 (choose option 1). For clinical questions, please contact Medical Information Services at Baxter at 800-933-0303, Monday through Friday 8:00am to 5:00 pm Central Time.
Quantity in Commerce 273,835 units
Distribution Worldwide Distribution-USA including Puerto Rico and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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