Events

Recall of Sorin Group perfusion system – Heater Cooler 1T devices

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LivaNova 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-2017-RN-01370-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-10-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01370-1
  • 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 livanova 1t machine requires a vacuum and sealing upgrade to mitigate against the risk of aerosolisation of the internal cooling water into the sterile operating zone during use.This design modification is unavailable for the 1t heater-cooler device, which is no longer manufactured nor sold. there have been no reported cases of the newly identified risk of ntm infections for patients exposed to the 1t heater-cooler device. however, livanova will replace users’ existing 1t heater coolers with 3t heater-cooler units that have undergone a vacuum and sealing upgrade at no cost to ensure that all customers have the latest, state-of-the art device.Livanova is also notifying users that the 3t device will be suspended from the australian register of therapeutic goods (artg) beginning 8 november 2017 for a period of up to 6 months. the reason for this suspension is that the minncare disinfectant is not listed on the artg with the same classification as the 3t device.
  • Action
    The LivaNova 1T machine is no longer manufactured or supplied by LivaNova, however, LivaNova has completed the development of a TGA approved correction for the later model 3T machine that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. LivaNova will replace all current 1T machines with corrected 3T machines at no cost to customers. The 1T will be permanently removed from the market and therefore obsolete.

Device

Sorin Group perfusion system – Heater Cooler 1T devices
  • Model / Serial
    Sorin Group perfusion system – Heater Cooler 1T devices All Serial Numbers ARTG Number 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd