Events

Recall of Spectra Optia Apheresis machine

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-00124-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00124-1
  • 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
    Terumo bcthas identified that pinhole leaks may occur due to stresses on the channel weld, particularly during long procedures on spectra optia. if leaks occur during use the procedure must be discontinued.Terumo bct has received reports relating to leaks in the channel of the tubing set of the spectra optia. these leaks have many different causes, including operator misloading. a very specific type of channel leak, a 'pinhole' leak at a specific location reported by customers primarily during long mnc procedures have been identified.
  • Action
    Terumo BCT is installing a modified filler at the next scheduled preventative maintenance to mitigate the risk of leakage. The device can continue to be used while awaiting the replacement filler. Users should be aware of the potential for leakage and cease any procedure if leakage is observed.

Device

Spectra Optia Apheresis machine

Manufacturer

Terumo BCT Australia Pty Ltd