Events

Recall of AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia 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-2018-RN-00052-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00052-1
  • 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
    During internal testing, medtronic identified the potential for a sterile barrier breach in the pouch of all lot numbers of the above listed products. other packaging configurations, such as integrated affinity nt hollow fiber oxygenator/cardiotomy venous reservoirs and perfusion tubing packs with affinity nt cardiotomy venous reservoirs are not affected by this issue. no other medtronic products are affected by this issue.
  • Action
    Medtronic is advising users to quarantine all unused, non-expired, affected product for return to Medtronic.

Device

AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.
  • Model / Serial
    AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.AFFINITY NT Cardiotomy Venous Reservoir stand-alone uncoatedCode 540, Model 61399409462All UnexpiredAFFINITY NT Cardiotomy Venous Reservoir stand-alone Trillium coated,Code 540T, Model 95249All UnexpiredARTG: Number: 132278 (Medtronic Australasia Pty Ltd - Reservoir, blood, cardiopulmonary bypass)
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA