Events

Recall of Advanced Perfusion System 1 (heart-lung bypass machine)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Terumo 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-2012-RN-01216-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2012-11-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01216-1
  • 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
    The manufacturer has received five reports between 2003 and 2012 of spontaneous power loss to the terumo system 1. in all reports the systems lost full power and did not switch to battery backup without warning. in one report the system re-booted automatically after about 30 seconds and in the remaining reports the system regained power after toggling the main power switch. in all of the reports the user was able to establish full function for the remainder of the case and the system did not exhibit the malfunction again.
  • Action
    An update to the instructions for use (IFU) is being issued to customers as an interim measure and the manufacturer's investigation into the root cause investigation is ongoing. Terumo is advising that should the investigation conclude that a corrective action is necessary, users will be notified.

Device

Advanced Perfusion System 1 (heart-lung bypass machine)
  • Model / Serial
    Advanced Perfusion System 1 (heart-lung bypass machine)Product Code: 801764Batch Numbers: 0006-0066, 0100-0311, 0313-0322, 1001-1027 & 1100-1429ARTG Number: 93976
  • Manufacturer
    Terumo Australia Pty Ltd

Manufacturer

Terumo Australia Pty Ltd