Events

Recall of ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CAREFUSION 303 INC..

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
    108315
  • Event Risk Class
    II
  • Event Initiated Date
    2011-11-08
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    A problem with the power supply board used with the alaris pc unit model 8015 only. a component on this power supply board is drawing extra charge and depleting the battery sooner than expected. the initial low battery message/ alarm will indicate that the battery has less than 30 minutes before depletion. however the battery power may not be available for the time indicated. if an affected power supply board is used in a pc unit the battery may not last as indicated by the low battery message/alarm. if the pc unit is not plugged into an a/c outlet as soon as the low battery message appears this could stop infusion or delay therapy which may result in serious injury and/or death.

Device

ALARIS SYSTEM - ALARIS SERVER MOBILE SYSTEMS MANAGER
  • Model / Serial
    Model Catalog: TC10005122 (Lot serial: n/a)
  • Product Description
    Alaris PC Model 8015
  • Manufacturer
    CAREFUSION 303 INC.

Manufacturer

CAREFUSION 303 INC.