Events

Recall of Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler 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-2016-RN-00886-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00886-1
  • 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 (sorin) have found that certain oxygenator mounting brackets that include tubing that connects the heater-cooler 3t water circuit to the oxygenator could be a source of re-contamination (with non-tuberculous mycobacteria) of a clean heater-cooler 3t’s water circuit. this tubing is not subjected to disinfection as per the ifu for the heater-cooler. if the heater-cooler 3t user failed to clean and disinfect the heater-cooler 3t resulting in contamination of the heater-cooler 3t and at some point later used oxygenator mounting bracket, the water from the contaminated heater-cooler 3t could cross-contaminate the oxygenator mounting bracket’s internal tubing in which biofilm could develop. if a non-contaminated heater-cooler 3t was later connected to an oxygenator mounting bracket that had been previously cross contaminated, the oxygenator mounting bracket could contaminate the clean heater-cooler 3t.
  • Action
    LivaNova will replace the affected bracket and is providing advice to users on how to dispose of the affected Oxygenator bracket. The existing brackets can be used until a replacement unit can be provided.

Device

Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater...
  • Model / Serial
    Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)D632 Adult Open System Bracket Catalogue Number: 05046Adult Oxy module Avant Bracket Catalogue Number: 050128Synthesis “C” BracketCatalogue Number: 050350Synergy Bracket Catalogue Number: 050131D626 Avant Holder Catalogue Number: 05040D630 Avant Holder Catalogue Number: 05041Synthesis Oxygenator Holder Catalogue Number: 050127ARTG # 194514
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd