Events

Recall of MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating-PLS-i gas exchanger in PLS sets -PLS gas exchanger in HIT -PLS sets-Quadrox-iR with Softline coating

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Maquet 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-2013-RN-00239-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00239-1
  • 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
    Outlet connector detachment may result in rapid blood loss which could cause serious injury or death. this issue was originally reported under recall rc-2012-rn-00551-3. although the correction implemented for the previous recall reduced the incidence rate of detachment from 0.01% to 0.001%, a patient death potentially attributed to detachment of the outlet connector was reported recently.
  • Action
    Customers are requested to continue to confirm the integrity of the oxygenator prior to use. The devices should only be used if the connector is secure. Maquet is implementing a stainless steel retainer clamp as a short term correction. A permanent mechanical fitting is currently under development and is expected to be implemented in late 2013. This action has been closed-out on 14/04/2016.

Device

MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, smal...
  • Model / Serial
    MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating-PLS-i gas exchanger in PLS sets -PLS gas exchanger in HIT -PLS sets-Quadrox-iR with Softline coating
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA