Events

Alerte De Sécurité sur DLPR Single Stage Venous Cannulae

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medtronic International Ltd..

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2011-12-20
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111220.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: update of the instructions for use of dlpr single stage venous cannulae medical device manufacturer, medtronic international ltd., is notifying customers that they are in the process of updating the instructions for use of dlpr single stage venous cannulae. medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use. the following statement referencing ventricular assist procedures will be identified as a contraindication in the updated instructions for use: “do not use this product for extended terms such as ventricular assist procedures.” according to the local supplier, the affected products have been distributed in hong kong. if you are in possession of the affected product, please contact your supplier for more information.

Device

DLPR Single Stage Venous Cannulae
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Update of the Instructions for Use of DLPR Single Stage Venous Cannulae
  • Manufacturer
    Medtronic International Ltd.

Manufacturer

Medtronic International 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
    DH