Events

Safety Alert for Alaris PC Unit, Model 8015

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
    2012-08-02
  • Event Date Posted
    2012-08-02
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120802.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 8015 the united states food and drug administration (fda) issued a class i recall concerning alaris pc unit, model 8015 (part of the alaris electronic infusion pump), manufactured by carefusion 303, inc. the affected unit had power supply board p/n tc 10005122 which were manufactured after january 2011 and were distributed from 1 january 2011 to 31 may 2012. according to fda, a component on the pc unit power supply board is causing an error code (120.4630): "system error" or "missing battery error" to occur. the error code is accompanied by both an audible alarm and a visual error message on the pc unit screen. if the error code occurs at start-up, the alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. if the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient. for details, please refer to fda website http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm314090.Htm and http://www.Fda.Gov/medicaldevices/safety/ listofrecalls/ucm314019.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 2 august 2012.

Device

Alaris PC Unit, Model 8015

Manufacturer

CareFusion 303