Events

Safety Alert for Alaris PC Unit Model 8000

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by CareFusion 303.

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
    2012-09-18
  • Event Date Posted
    2012-09-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120918.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: carefusion alaris pc unit model 8000 the health canada has issued a type i recall concerning alaris pc unit model 8000, manufactured by carefusion 303, inc. according to the health canada, the pc unit model 8000, when used with pump or syringe modules, may under certain conditions display an incorrect total dose when programmed to deliver bolus dose. the pump or syringe module delivers the actual programmed bolus dose (and associated volume to be infused) regardless of the displayed total bolus dose. this can cause confusion leading to improper treatment potentially causing injury or death. according to the local supplier, the affected products were not distributed in hong kong for details, please refer to the following health canada website: for details, please refer to the following health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/ _list/rec-ret_md-im_date_july-sept_2012-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 september 2012.

Device

Alaris PC Unit Model 8000
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: CareFusion Alaris PC Unit Model 8000
  • Manufacturer
    CareFusion 303

Manufacturer

CareFusion 303