Events

Recall of Device Recall ABACUS TPN Calculation Software, Baxa

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
    66989
  • Event Risk Class
    Class 2
  • Event Number
    Z-0539-2014
  • Event Initiated Date
    2013-12-03
  • Event Date Posted
    2013-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124436
  • 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
    medical Computers and software - Product Code LNX
  • Reason
    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.

Device

Device Recall ABACUS TPN Calculation Software, Baxa
  • Model / Serial
    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
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • 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