Events

Alerte De Sécurité sur Level Sensor II Pads

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.

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
    2011-08-18
  • 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_20110818.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 removal: terumo level sensor ii pads terumo cardiovascular systems (terumo cvs) issued an urgent product removal of level sensor ii pads. the removal followed an investigation about the reports of level sensor ii pads detaching from the surface of the venous reservoir. the affected products are of an older population that is labeled with a manufacture date but not an expiration date. they were shipped between december 28, 2000 and january 1, 2010. the adhesive is intended for use within two years of the date of manufacture, otherwise it may detach. the detachment of the level sensor pad from the venous reservoir compromises the capabilities of the level detection system, preventing the ultrasonic level sensor from maintaining adequate contact with the reservoir. the risk caused by the detachment of the level sensor pad varies with the type of perfusion system that it is used with. in serious cases, it may cause interruption to blood flow due to unanticipated pump stop, which in turn, may lead to reduction in blood pressure and severe injury. according to the local supplier, there is no record of distribution of the affected product in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Level Sensor II Pads
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Level Sensor II Pads
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems