Events

Recall of Sorin Group perfusion system – Heater Cooler 3T 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-01368-1
  • 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-01368-1
  • 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
    Livanova is issuing a recall for product correction to inform users about the retrofit of their heater cooler 3t devices to implement a vacuum and sealing upgrade. this modification to the internal design of the 3t heater-cooler device will collect any aerosols that are potentially contaminated with nontuberculous mycobacterium (ntm), preventing those aerosols from entering into the sterile operating field.Livanova is also notifying 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. however, during this period, livanova will be able to supply loan units on an as-needed, no-charge basis to ensure continuity of clinical practice.
  • Action
    LivaNova has completed the development of a TGA approved correction that mitigates against this potential contamination by preventing dispersion of aerosols produced by the heater-cooler in the operating room. This correction will be implemented by an onsite enhancement of units currently in use by LivaNova service personnel or a local agent. Although this issue is less likely when the 3T device’s water system is maintained according to the current IFU, this product correction will mitigate against the reasonably foreseeable hazard of patient infection which may be potentiated by poor maintenance practices.

Device

Sorin Group perfusion system – Heater Cooler 3T devices

Manufacturer

LivaNova Australia Pty Ltd