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U.S. Department of Health and Human Services

Class 1 Device Recall ABACUS TPN Calculation Software

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 Class 1 Recall
ABACUS TPN Calculation Software
see related information
Date Posted May 12, 2014
Recall Status1 Open
Recall Number Z-1566-2014
Recall Event ID 67884
Product Classification System/Device, Pharmacy Compounding - Product Code NEP
Product ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166 ABACUS 3.1 DE, 8300-0167 ABACUS 3.1 CE, 8300-0168 ABACUS 3.1 SE, 8300-0169 ABACUS 3.1 ME. ABACUS is a Windows - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for Total Parenteral Nutrition (TPN) order calculations.
Code Information Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169
Recalling Firm/
Manufacturer
Baxter Corporation Englewood
14445 Grasslands Dr
Englewood, Colorado 80112-7062
For Additional Information Contact Kimberly Zizik
303-617-2242
Manufacturer Reason
for Recall
1. ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders. 2. ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix resulting in an over dilution. 3. All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly. 4. All software v
FDA Determined
Cause 2
DESIGN: Software Design
Action Baxter sent an Urgent Device Correction letter dated April 21, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. . 1. Follow safe compounding practice, which includes 1) using of the Summary button to verify the order against the calculated amounts prior to completing the order, 2) verifying that the ordered ingredients and quantities displayed in the software and printed on the Bag label and the Solution Formula label match the PN prescription prior to preparation, and 2) using a filter for administration of a PN bag. Use of the ABACUS Software must comply with your facility's policies, procedures, and training, including verification that all information entered into the ABACUS Software is accurate and clinically appropriate. 2. To determine if any of these Issues are present in your current ABACUS configuration, please note the following immediate actions should be taken: "Double Salts: Baxter contacted all facilities installed by Baxter with ABACUS v3.1 to correct the Double Salts Issue via telephone between April 4, and April 16, 2014.To avoid the Double Salts Issue, a pharmacy installed with ABACUS v3.1 should 1) ensure the "Include non-electrolyte ion contributions in balance" checkbox is checked for all salt-based templates, and 2) compare the ordered amount of salts to the delivered amount on the Ions tab in ABACUS. "Sterile Water Added to TPN with Pre-Mix: Customer should ensure that all premix not intended for use on the compounder are marked as "Pre-Mix PN Solution" type in the Formulary. Customer should then check the template, under the "Infusion" tab, to ensure the "Infusion Mode" is set to "Pre-Mix (Cyclic)". "Premasol CaP04 Curve Data Points: Review Attachment 1 for information relevant to the use of calcium phosphate curves for Premasol 3% Dex 25.
Quantity in Commerce 2034
Distribution Worldwide Distribution - USA nationwide, Canada, Colombia, Dominican Republic, Panama, Austria, Bosnia Herzegovina, Bulgaria, Bahrain, Estonia, France, Germany, Georgia, Hungary, Ireland, Israel, Jordan, Kuwait, Latvia, Morocco, Oman, Qatar, Saudi Arabia, Slovenia, Slovakia, South Africa, Switzerland, United Arab Emirates, United Kingdom, Hong Kong, and Taiwan.
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.
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