Events

Recall of PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge 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-00978-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-08-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00978-1
  • 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 plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegia and / or crystalloid cardioplegia solutions during extracorporeal circulation. the plegiox heat exchanger consists of two liquid circulations strictly separated from each other by a separating barrier to separate both liquids from each other and to effect thermal transfer at the same time; the design of the plegiox uses hollow fibres made of polyurethane. hollow fibres serve as barrier separating the circulating liquids while effecting thermal transfer. maquet cardiopulmonary gmbh (mcp) internal investigations have revealed that the specification of the performance factor (pf) at flow rates of 1 litre per minute is not always maintained as defined in instruction for use (ifu). deviations up to minus 20% were identified during in-house testing. zero adverse events have been reported in relation to this insufficiency.
  • Action
    Getinge seeks to notify users that: When using the PLEGIOX, the flow rate should be no higher than 500 ml/min to ensure reasonable performance.

Device

PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those ...
  • Model / Serial
    PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.Reference Numbers: 703006246, 703006285, 703006317ARTG Number: 158781
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

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