Events

Recall of Trima Accel Automated System (Apheresis unit)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo BCT 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-2013-RN-00377-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-04-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00377-1
  • 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
    There is the potential risk for an air embolism if air is delivered to a donor if the donor is connected prior to completion of loading the tubing set when using the trima accel system.
  • Action
    Terumo BCT is implementing a safety enhancement in the Trima Accel system software version 6.0.6 that modifies the current product bag air removal and tubing set test sequence. This new functionality will redirect the air from the product bags and cassette into the vent bag instead of out the needle line.

Device

Trima Accel Automated System (Apheresis unit)
  • Model / Serial
    Trima Accel Automated System (Apheresis unit)Catalogue Number: 81000All serial numbers affectedARTG Number: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd