Events

Rappel de Medtronic Paradigm Insulin Infusion Sets

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-2013-RN-00587-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-06-12
  • 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-2013-RN-00587-1
  • 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
    Medtronic diabetes has become aware of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the connector on the affected sets. if this occurs, the insulin can temporarily block the vents in the connector that allow the pump to properly prime. exposure of the inside of the infusion set connector to fluid is most likely to occur if insulin is spilled on the top of the insulin reservoir when the reservoir is removed from the transfer guard after filling the reservoir from a vial of insulin.
  • Action
    Medtronic is providing additional safety information to consumers and health professionals to ensure the vents in the connector are not blocked. The devices instructions for use will be updated with this information. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-paradigm-insulin-infusion-sets-130621.htm .

Device

Medtronic Paradigm Insulin Infusion Sets

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