Events

Recall of ABACUS TPN Calculation Software

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Corporation Englewood.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67884
  • Event Risk Class
    Class 1
  • Event Number
    Z-1566-2014
  • Event Initiated Date
    2014-04-02
  • Event Date Posted
    2014-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126581
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System/device, pharmacy compounding - Product Code NEP
  • Reason
    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.
  • 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

Device

ABACUS TPN Calculation Software
  • Model / Serial
    Product Code 8300-0045, 8300-0046, 8300-0047, 8300-0156, 8300-0157, 8300-0158, 8300-0166, 8300-0167, 8300-0168, 8300-0169
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Manufacturer Address
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA