Events

Recall of Spectra Optia Apheresis System (intended to be used to separate blood extracted from a donor or patient into various components, while the donor/patient is connected to the 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-2015-RN-00862-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-09-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00862-1
  • 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 have been reports of data entry errors that cause the system to calculate a patient total blood volume (tbv) that is abnormal for that specific patient. the error can occur under the following circumstances: ? the operator accidentally switches the values for height and weight when entering the data. ? the patient is weighed and measured in units that are different from what the operator selects when entering the data. ? the operator enters a height and a weight that are not accurate. if the operator does not enter correct data, the patient may receive excess anticoagulant (ac) or the outcome of the procedure may be affected. this issue can have the greatest effect on small or compromised patients for whom an abnormally high tbv calculation could lead to hypocalcemia.
  • Action
    Terumo BCT is reminding all users to verify that the entered height, weight and calculated TBV are correct in order to mitigate this risk. Instructions for use and confirmation screens are displayed on the system screens before the operator starts the procedure. In addition, Terumo is developing modifications to the Spectra Optia system software to further mitigate the potential for data entry errors. When the software is available, it will be installed during a scheduled preventive maintenance visit. This action has been closed-out on 02/05/2017.

Device

Spectra Optia Apheresis System (intended to be used to separate blood extracted from a donor or p...
  • Model / Serial
    Spectra Optia Apheresis System (intended to be used to separate blood extracted from a donor or patient into various components, while the donor/patient is connected to the unit)ARTG Number: 130529
  • Product Classification
    Gastroenterology-Urology Devices
  • Manufacturer
    Terumo BCT Australia Pty Ltd

Manufacturer

Terumo BCT Australia Pty Ltd