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U.S. Department of Health and Human Services

Class 2 Device Recall ABACUS TPN Calculation Software, Baxa

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 Class 2 Recall
ABACUS TPN Calculation Software, Baxa
see related information
Date Posted December 18, 2013
Recall Status1 Open
Recall Number Z-0539-2014
Recall Event ID 66989
Product Classification Medical Computers And Software - Product Code LNX
Product ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows® - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes
Code Information Product Code: 8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047
Recalling Firm/
Manufacturer
Baxter Corporation Englewood
14445 Grasslands Dr
Englewood, Colorado 80112-7062
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutrition (TPN) Calculation Software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's TPN order as a result of data corruption.
Action Baxter sent an Urgent Device Correction letter dated December 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the patient order against the final bag label as part of the TPN acceptance procedure to ensure that the patient's TPN order is correct. Customers will be contacted by Baxter to arrange for installation of a software upgrade specific to their compounder's configuation. Customers were asked to acknowledge the receipt of this notification by completing the attached Customer Reply Form and return it to Baxter by fax to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. If the product was distributed to other facilities customers were instructed to notify end-user customers in accordance with their customary procedures. Customers with questions were instructed to call 1-800-678-2292. For questions regarding this recall call 800-422-9837.
Quantity in Commerce 2,211
Distribution Nationwide Distribution
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
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