Events

Avis De Sécurité sur Heater-Cooler

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par LivaNova.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-11-11
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Over the past two years, livanova1 and the broader cardiac surgery community has learned a great deal about a newly-identified infection risk to open-heart surgery patients called nontuberculous mycobacterium (“ntm”). ntm are widespread in nature and are commonly found in the soil, natural water, drinking water distribution systems, and household and building plumbing, especially in recirculating hot water systems in hospitals and apartment buildings. ntm are typically not harmful, but in rare cases may cause infections in very ill patients or individuals with compromised immune systems. as the market leader for heater-cooler devices, livanova is committed to patient safety and supporting the clinical community who use our devices. we take seriously the rare but concerning potential risk of ntm infections. we are committed to ensuring clinician confidence in our heater-cooler devices, which are a critical part of cardiac surgery procedures. in this regard, we would like to provide you with a further update on this important industry issue. .

Device

Heater-Cooler
  • Modèle / numéro de série
  • Manufacturer
    LivaNova

Manufacturer

LivaNova