Events

Recall of Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, Oasis

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Atrium Australia - Pacific Rim Pty Limited.

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-2013-RN-01159-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-11-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01159-1
  • 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
    Atrium medical has become aware that the force required to detach the tubing from the drain may be lower than atrium medical's product specifications. the manufacturer has received reports for leaking of blood or disconnection of the drain at the connection point of the ats access line and the chest drain. the leaks or disconnection occurred following usage of the drain in excess of 2 days and typically were related to movement of the patient within the institution.
  • Action
    Atrium Medical is advising their customers to quarantine affected products and use an appropriate substitute device. If an adequate substitute is not available customers are advised to review the substitution list and contact Atrium for assistance in obtaining the substitute device. It is further advised that in the event of an emergency situation the affected devices can continue to be used provided work around instructions are followed.

Device

Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of ...
  • Model / Serial
    Atrium Chest drains that contain an Autotransfusion (ATS) System access line (for re-infusion of autologous blood in postoperative and trauma blood loss management)Systems affected - Ocean, OasisProduct Codes: 2050-300, 3650-100Lot/Serial Numbers: 10883118, 10891209, 10899344, 10883101, 10891238, 10906323ARTG Number: 126675
  • Product Classification
    Anesthesiology Devices
  • Manufacturer
    Atrium Australia - Pacific Rim Pty Limited

Manufacturer

Atrium Australia - Pacific Rim Pty Limited
  • Source
    DHTGA