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The US Food and Drug Administration (FDA) has announced a Class I recall of Baxter Corporation Englewood’s ABACUS Total Parenteral Nutrition (TPN) Calculation Software, versions 3.1, 3.0, 2.1, and 2.0.
Baxter has received 2 reports of malfunctioning software and said errors with this software may cause adverse effects.
ABACUS TPN Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas.
The errors explained
Due to software failures, the following errors may occur:
- ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders.
- ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix, resulting in an over-dilution.
- All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly.
- All software versions of ABACUS may display an inaccurate estimation for calcium and phosphate precipitation in certain circumstances where multiple ingredients provide calcium.
If any of these failures occur, patients may be at risk of developing overdose symptoms. The symptoms are varied and depend on the type of software failure and composition of the fluid being compounded.
Symptoms may be non-specific and include nausea, vomiting, dizziness, or fatigue. Some more severe symptoms include cardiac arrhythmia, pulmonary edema, congestive heart failure, and seizures. A fatal outcome is possible, especially in the high-risk population.
Actions to take
Baxter is recommending that customers contact the company to ensure the ABACUS software is configured correctly.
Customers with a software version earlier than 3.1 will have software version 3.1 installed, which addresses the issues that prompted the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.
Baxter has also requested that customers follow safe compounding practices. Namely, use the “Summary” button to verify the order against the calculated amounts prior to completing the order.
In addition, verify 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 use a filter for administration of a PN bag.
For more information on the recall, see the FDA’s recall notice, or contact Baxter at 303-617-2242. For technical support, call 1-800-678-2292 or email [email protected].
To report adverse reactions or quality problems related to this product, visit the FDA’s MedWatch website. 
The US Food and Drug Administration (FDA) has announced a Class I recall of Baxter Corporation Englewood’s ABACUS Total Parenteral Nutrition (TPN) Calculation Software, versions 3.1, 3.0, 2.1, and 2.0.
Baxter has received 2 reports of malfunctioning software and said errors with this software may cause adverse effects.
ABACUS TPN Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas.
The errors explained
Due to software failures, the following errors may occur:
- ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders.
- ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix, resulting in an over-dilution.
- All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly.
- All software versions of ABACUS may display an inaccurate estimation for calcium and phosphate precipitation in certain circumstances where multiple ingredients provide calcium.
If any of these failures occur, patients may be at risk of developing overdose symptoms. The symptoms are varied and depend on the type of software failure and composition of the fluid being compounded.
Symptoms may be non-specific and include nausea, vomiting, dizziness, or fatigue. Some more severe symptoms include cardiac arrhythmia, pulmonary edema, congestive heart failure, and seizures. A fatal outcome is possible, especially in the high-risk population.
Actions to take
Baxter is recommending that customers contact the company to ensure the ABACUS software is configured correctly.
Customers with a software version earlier than 3.1 will have software version 3.1 installed, which addresses the issues that prompted the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.
Baxter has also requested that customers follow safe compounding practices. Namely, use the “Summary” button to verify the order against the calculated amounts prior to completing the order.
In addition, verify 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 use a filter for administration of a PN bag.
For more information on the recall, see the FDA’s recall notice, or contact Baxter at 303-617-2242. For technical support, call 1-800-678-2292 or email [email protected].
To report adverse reactions or quality problems related to this product, visit the FDA’s MedWatch website.
The US Food and Drug Administration (FDA) has announced a Class I recall of Baxter Corporation Englewood’s ABACUS Total Parenteral Nutrition (TPN) Calculation Software, versions 3.1, 3.0, 2.1, and 2.0.
Baxter has received 2 reports of malfunctioning software and said errors with this software may cause adverse effects.
ABACUS TPN Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas.
The errors explained
Due to software failures, the following errors may occur:
- ABACUS v3.1 may calculate quantities of electrolytes that are double the expected values during the creation of TPN orders.
- ABACUS v3.1 may automatically add additional sterile water to a formula equal to the volume of a premix, resulting in an over-dilution.
- All software versions of ABACUS software display the calcium phosphate curve points for Premasol incorrectly.
- All software versions of ABACUS may display an inaccurate estimation for calcium and phosphate precipitation in certain circumstances where multiple ingredients provide calcium.
If any of these failures occur, patients may be at risk of developing overdose symptoms. The symptoms are varied and depend on the type of software failure and composition of the fluid being compounded.
Symptoms may be non-specific and include nausea, vomiting, dizziness, or fatigue. Some more severe symptoms include cardiac arrhythmia, pulmonary edema, congestive heart failure, and seizures. A fatal outcome is possible, especially in the high-risk population.
Actions to take
Baxter is recommending that customers contact the company to ensure the ABACUS software is configured correctly.
Customers with a software version earlier than 3.1 will have software version 3.1 installed, which addresses the issues that prompted the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.
Baxter has also requested that customers follow safe compounding practices. Namely, use the “Summary” button to verify the order against the calculated amounts prior to completing the order.
In addition, verify 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 use a filter for administration of a PN bag.
For more information on the recall, see the FDA’s recall notice, or contact Baxter at 303-617-2242. For technical support, call 1-800-678-2292 or email [email protected].
To report adverse reactions or quality problems related to this product, visit the FDA’s MedWatch website.