Events

Alerte De Sécurité sur Venous Arterial Aortic Cannula

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par manufacturer #121.

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
  • Numéro de l'événement
    2009DM-0004493
  • Date
    2018-04-16
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=50
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données

Device

Venous Arterial Aortic Cannula
  • Modèle / numéro de série
    intra-aortic occlusion devices
  • Description du dispositif
    ENDORETURN arterial cannula: is indicated for patients who undergo cardiopulmonary bypass. Its purpose is to deliver oxygenated blood for cardiopulmonary bypass during surgery. The ENDORETURN cannula with hemostasis valve allows catheter introducer: it is indicated for patients that require the introduction of catheters. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. Arterial cannulaDIRECT: and the AUTOINCORTER are indicated for patients who experience cardiopulmonary bypass. The aim of the arterial cannula is to deliver oxygenated blood for cardiopulmonary bypass during surgery. AUTOINCYCOR: the AUTOINCORTER is intended to be used with the HEARTPORT arterial cannula. Its purpose is the incision of the aorta and the introduction of the cannula into the aorta. Arterial cannulaENDORETUM: is indicated for patients who experience a cardiopulmonary derivation. Its purpose is to deliver blood-oxygenated for cardiopulmonary bypass during surgery. The CANORETUM cannula with hemostasis valve allows the hemostatic introduction and removal of the ENDOCLAMP aortic catheter from HEARTPORT.Vain of the catheter introducer: it is indicated for patients requiring the introduction of catheters and the removal of the aortic catheterENDOCLAMP from HEARTPORT. Its purpose is the hemostatic introduction and removal of aortic catheter ENDOCLAMP from HEARTPORT. DIRECTFLOW arterial cannula: and the autoinclusor are indicated for patients who undergo cardiopulmonary bypass. The aim of the DIRECTFLOW cannula is to deliver oxygenated blood for cardiopulmonary diversion during surgery. The arterial cannula
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA