Events

Alerte De Sécurité sur Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae

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 Cardiovascular Systems 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
    2014-03-07
  • Date de publication de l'événement
    2014-03-07
  • 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_20140307c.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 malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae medical device manufacturer, terumo cardiovascular systems corporation, has issued a medical device safety alert concerning all lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae with catalogue numbers 4934, 4934x, 4935, 4936, 4936x, 16472 and 16473. during in-process inspection, terumo cardiovascular systems (terumo cvs) identified exposed basket wire on certain product lots of sarns malleable dual-stage venous return cannulae and sarns dual-stage venous return cannulae. according to the manufacturer, the presence of exposed basket wire on the outside surface of the cannulae may be detected by the surgical team prior to patient exposure. if not detected, the exposed wire could result in tissue damage and a remote chance of air being introduced into the cardiopulmonary bypass circuit. the presence of exposed basket wire on the inside surface of the cannulae is more difficult to detect. the exposed wire could result in turbulence in blood flow increasing risk of hemolysis. terumo cvs has not received any reports of exposed basket wire from customers and there are no reported injuries from the observed defect. terumo cvs is recalling all affected cannulae. according to the local supplier, the affected products were not distributed to hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 07 march 2014.

Device

Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation