Events

Safety Alert for ABACUS Total Parenteral Nutrition Calculation Software

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Baxter.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-12-13
  • Event Date Posted
    2013-12-13
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131213a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: baxter abacus total parenteral nutrition calculation software medical device manufacturer, baxter, has issued a field safety notice concerning abacus total parenteral nutrition (tpn) calculation software distributed between may 2006 and may 2013 (software versions: 2.0 through 3.0). the possibility exists that a patient could receive another patient’s tpn order due to data corruption. while no patient harm has been reported for this issue, provision of the wrong admixture to patients receiving tpn therapy may cause severe complications, potentially triggering a chain of complications that may lead to a fatal outcome. baxter is requesting users to be consistent with good pharmacy practice, and 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. furthermore, the tpn order entry software v3.1 upgrades will be arranged. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 13 december 2013.

Device

ABACUS Total Parenteral Nutrition Calculation Software
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Baxter ABACUS Total Parenteral Nutrition Calculation Software
  • Manufacturer
    Baxter

Manufacturer

Baxter