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U.S. Department of Health and Human Services

Class 2 Device Recall Sigma Spectrum Infusion Pump with Master Drug Library V6, V8, Spectrum IQ with Dose IQ Safety Softwa

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  Class 2 Device Recall Sigma Spectrum Infusion Pump with Master Drug Library V6, V8, Spectrum IQ with Dose IQ Safety Softwa see related information
Date Initiated by Firm January 06, 2021
Create Date February 25, 2021
Recall Status1 Open3, Classified
Recall Number Z-1150-2021
Recall Event ID 86788
510(K)Number K042121  K133801  K173084  
Product Classification Pump, infusion - Product Code FRN
Product Infusion Pump
Code Information Infusion Pump Product codes: 35700ABB, 35700BAX, and 35700BAX2  Battery codes: 35083, 35162, 35195, and 35724.  Infusion Pump Product codes: 35700ABB, 35700BAX, 35700BAX2 3570009  Battery codes: 35223 and 36010
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
711 Park Ave
Medina NY 14103-1036
For Additional Information Contact Jacqueline Kunzler
585-798-3901
Manufacturer Reason
for Recall		 Battery performance issues related to prolonged storage.
FDA Determined
Cause 2		 Under Investigation by firm
Action 1. If your facility is currently installing or planning to install new pumps and batteries that are currently in storage, please contact Baxter Technical Assistance at 800 356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time, for further instructions. The duration and conditions under which the new batteries have been stored will help determine whether battery damage due to depletion is likely. 2. For facilities currently using Spectrum pumps: ¿ If you are not experiencing recurrent battery alerts/alarms, continue using the Spectrum battery modules as indicated. ¿ If you are experiencing recurrent battery alerts/alarms, please operate your pumps on AC power and contact Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm Eastern Time. 3.Baxter is advising all customers who plan prolonged storage of Spectrum pumps and batteries to ensure the following: ¿ Batteries are charged to 2 or 3 bars prior to storage (do not fully charge); ¿ Batteries are stored between -10 and +35 degrees C (14 and 95 degrees F); ¿ Batteries are removed from the pump and stored independent of the pumps; and ¿ Batteries are recharged every six months while in storage. Not following these storage instructions can result in battery damage and/or reduced capacity and life of the battery. 4. The Spectrum Installation & Maintenance Guide/Service Manual, which can be accessed at https://service.baxter.com/tsportal/, describes a Battery Life Test that can be used to test for battery damage due to depletion. This test is recommended as part of routine maintenance. 5. Customers experiencing recurrent battery alerts/alarms should follow the instructions described in step 2 above. Do not attempt to resolve this issue by performing the battery recovery as described in the Technical Service Bulletins below. The battery recovery process is intended to recover a battery locked in a low c
Quantity in Commerce 589,704 total units
Distribution Domestic Distribution: ST, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico. International Distribution: Canada, Barbados, Bermuda, St. Thomas, Guyana, Trinidad and Tobago, Jamaica and Nassau Bahamas.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = BAXTER HEALTHCARE CORPORATION
510(K)s with Product Code = FRN and Original Applicant = SIGMA INTL.
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