Events

Rappel de AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2018-RN-00052-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-01-16
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00052-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Modèle / numéro de série
    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
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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