Events

Recall of ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Bard Australia Pty Ltd.

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
    RC-2017-RN-00534-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-07-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00534-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    An issue regarding the use of the arctic sun 5000 temperature management system, in excess of 2,000 system hours, without conducting preventative maintenance has been identified. this issue may result in failure of certain components, in particular, the mixing pump of the system. the mixing pump runs continuously during operation and its failure may cause the system to cease functioning as intended. therefore, resulting in no availability of cooling or rewarming therapy for the patient. to date, bard australia has not received adverse reports of injuries or diseases related to this issue.
  • Action
    Bard Australia is updating the Operators Manual and the Service Manual for the ARCTIC SUN 5000 Temperature Management System. Customers are advised to examine their inventory for affected devices to determine their total system hours of use by following the instructions detailed in the recall letter. Customers with devices approaching or exceeding 2,000 system hours are requested to contact their local Bard representative for further information. Customers with devices that have less than 2,000 hours are reminded to address potential issues before their occurrence in order to maintain device availability. In the event of a device failure, customers are advised to utilise alternative conventional methods for patient temperature control.

Device

ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)
  • Model / Serial
    ARCTIC SUN 5000 Temperature Management System (220-240 V Australia)Product Code: 5000-01-03ARTG Number: 150422
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd