Events

Alerte De Sécurité sur Sarns™ Antegrade Cardioplegia Cannula

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

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
    2012-05-14
  • Date de publication de l'événement
    2012-05-14
  • 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_20120514.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
    Medical device safety alert: terumo sarns™ antegrade cardioplegia cannula medical device manufacturer, terumo cvs corporation, has issued an urgent field safety notice concerning sarns™ antegrade cardioplegia cannula. the manufacturer is recalling certain lots of the devices as they found a foreign substance on the inner surface of some cannulae tips. their preliminary investigation revealed that the substance can be dislodged from the cannula surface. moreover, the substance was likely deposited during the molding process, but the exact composition of the substance is still undetermined; and any unit manufactured within the last three years on the same mold could potentially be affected. the resulting patient harm would vary from a localized inflammatory response in the coronary vasculature that could result in post-operative myocardial irritability to the creation of an embolus that would disrupt or block coronary blood flow and could result in post-operative myocardial infarction. if particulate escaped the coronary arteries and embolized elsewhere in the vasculature, the results could vary from a localized inflammatory response to organ dysfunction or stroke. there have been no reports of patient injury related to this issue. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 may 2012.

Device

Sarns™ Antegrade Cardioplegia Cannula
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Sarns™ Antegrade Cardioplegia Cannula
  • Manufacturer
    Terumo CVS Corporation

Manufacturer

Terumo CVS Corporation