Events

Alerte De Sécurité sur arterial filter affinity

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 Medtronic Perfusion Systems || Medtronic México S.R.L de Cv.

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
  • ID de l'événement
    I1611-536
  • Numéro de l'événement
    2010DM-0004625-R1
  • Date
    2016-11-28
  • 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=112
  • 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

arterial filter affinity
  • Modèle / numéro de série
    BB841, specific lots.
  • Description du dispositif
    Description: AFFINITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter micro-symbols of the largest size circuit in microns specified, for periods of up to 6 hours during cardiopulmonary bypass surgery. Use: these filters are indicated for use in all cardiopulmonary bypass procedures for the removal of particles and gaseous micro piston. The filters are single-use, sterile, non-pyrogenic devices designed to filter micro-plots larger than the specified micron size from the circuit of periods of up to six hours during cardiopulmonary bypass surgery. AFFINITY351 / cb351 arterial filter (38μ, 351 / cb351 arterial blood filter (20μ arterial blood filter) AFFFITY arterial blood filters are sterile, non-pyrogenic devices for single use and are designed to filter microcircuits of the circuit greater than the specified micron size, for periods of up to 6 hours during cardiopulmonary bypass surgery AFFINITY arterial blood filters carmeda (cb351 and cb 353) are coated with an impermeable bioactive surface (heparin), which provides blood contact surfaces resistant to thrombus formation TRILLIUM AFFINITRY NT 541t: the membrane oxygenator with integrated CVR AFFINITY NT (plasma-resistant defibra oxygenator (PRF) with bioactive surface TRILLIUM is designed to be used in an extracorporeal perfusion circuit to collect venous blood and blood-pitched cardiotomy, to heat or cool the blood, and to oxygenate and eliminate the dioxide blood carbon during systemic cardiopulmonary bypass procedures for up to 6 hours.
  • Manufacturer
    Medtronic Perfusion Systems || Medtronic México S.R.L de Cv

Manufacturer

Medtronic Perfusion Systems || Medtronic México S.R.L de Cv
  • 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
    NIDFSINVIMA