Medical Devices

Baxter Corporation Englewood, ABACUS Total Parenteral Nutrition Calculation Software, Versions 3.1, 3.0, 2.1, and 2.0 - Software Errors May Cause Toxic or Overdose Symptoms

Recall Class: Class I

Date Recall Initiated: April 2, 2014

Products: ABACUS Total Parenteral Nutrition Calculation Software, v3.1, v3.0, v2.1, and v2.0

Product Codes 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169

The affected software was manufactured from May 17, 2006 through May 28, 2013 and distributed from May 17, 2006 through March 17, 2014.

Use: ABACUS Total Parenteral Nutrition (TPN) Calculation Software is a Windows-based software application used by pharmacists to calculate or order TPN formulas.  TPN is used to meet the nutritional needs of patients who cannot eat or drink by mouth and is used in the hospital or in the home by a licensed health care professional.

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, and combinations of multiple ingredients, fractional doses from larger volumes.

Recalling Firm:
Baxter Corporation Englewood
14445 Grasslands Drive
Englewood, Colorado 80112-7062

Reason for Recall:

The firm received 2 reports in which the device has malfunctioned.

Due to software failures, the firm has identified the following potential issues when using ABACUS TPN calculation software:

  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; and
  4. 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 were to occur, patients may be at risk for toxic or 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 a problem with the rate or rhythm of the heartbeat (cardiac arrhythmia), an abnormal buildup of fluid in the air sacs of the lungs, which leads to shortness of breath (pulmonary edema), congestive heart failure and seizures. A fatal outcome is possible, especially with the high risk population.

Public Contact:

Health care professionals: For questions about the actions to be taken, contact Baxter Technical Support at 1-800-678-2292, Monday through Friday, 6 am - 5 pm, Mountain Time or by email at COtechsupport@baxter.com. For questions about the recall, contact Baxter at 303-617-2242.

Patients having this procedure at home: For questions about this recall, contact your home health care agency or doctor.

FDA District: Denver District Office

More Information about this Recall:

On April 21, 2014, Baxter sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer and Baxter.

Baxter’s letter directed customers to follow safe compounding practices, and contact Baxter to ensure that the ABACUS software is configured correctly. Baxter is removing the user’s permission to edit the TPN order template configuration.  Customers with a software version earlier than 3.1 will have software version 3.1 installed that addresses the issues in the recall. In addition, Baxter Support Services will schedule upgrades and assist customers with establishing the proper ABACUS configuration in the customers’ facilities.

Baxter requests customers take the following actions:

  1. Follow safe compounding practices, which include:
    1. Use the Summary button to verify the order against the calculated amounts prior to completing the order.
    2. 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
    3. Use 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, the following immediate action should be taken:
    1. Double Salts Issue - Those users with ABACUS v3.1 should perform the following actions:
      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.
        NOTE: From April 4 through April 16, 2014 Baxter phoned all facilities installed by Baxter with ABACUS v3.1 to correct the Double Salts Issue.
    2. 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)".
    3. Premasol CaP04 Curve Data Points - Review Attachment 1 of the customer notification letter for information relevant to the use of calcium phosphate curves for Premasol 3%  Dex 25 (no cysteine) and Premasol 0.5% Dex 10% (no cysteine).
    4. Divalent lon Solution - If operators have a Calcium Ingredient Group, operators should ensure that the Calcium Ingredient Group does not contain calcium chloride.

About Class I Recalls:

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 05/22/2014
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