Events

Alerte De Sécurité sur EXCOR® arterial cannula with graft CGRG-021

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

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
    2012-08-07
  • Date de publication de l'événement
    2012-08-07
  • 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_20120807.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: berlin heart excor® arterial cannula with graft cgrg-021 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a field safety notice concerning excor® arterial cannula with graft cgrg-021 manufactured by berlin heart gmbh. during the period from october 2011 to july 2012, the excor® arterial cannula with graft cgrg-021 (6 mm graft arterial cannula) was subject to a limited market launch with product monitoring. while evaluating the clinical data, berlin heart received an increasing number of cases in which, according to customer feedback, seroma and bleeding in the region of the graft material occurred. an analysis of the cause is in process. there is the risk that for patients who are provided with the excor® arterial cannula with graft cgrg-021 could experience seroma and bleeding, and as a result may require re-operation with a cannula exchange in individual case. on the basis of this information, berlin heart has decided to recall the excor® arterial cannula with graft cgrg-021 from the market. all other arterial cannulae from the product range continue to be available without limitation and can be used for implantations. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 august 2012.

Device

EXCOR® arterial cannula with graft CGRG-021
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Berlin Heart EXCOR® arterial cannula with graft CGRG-021
  • Manufacturer
    Berlin Heart GmbH

Manufacturer

Berlin Heart GmbH