Events

Recall of Spectra Optia Apheresis System with Software Version 11

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-2014-RN-00963-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00963-1
  • 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
    A defect in optia version 11 sw can cause an unexpected behaviour to the rinseback option when the wbc or platelet counts are updated during the run and they are sufficiently different from the previous counts. the absence of rinseback could result in loss of rbc potentially resulting in limited illness or injury. unintended rinseback carried out on a very small patient could result in symptomatic hypervolemia. no serious injury or deaths have been associated with this behaviour.
  • Action
    Terumo BCT is actively working on a software update to correct this behaviour. Once this software is available affected devices will be updated. End users are being provided work around instructions to ensure the continued safe use of the device. This action has been closed-out on 14/07/2016.

Device

Spectra Optia Apheresis System with Software Version 11
  • Model / Serial
    Spectra Optia Apheresis System with Software Version 11 Catalogue Number: 61000ARTG Numbers: 130529
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd