Events

Alerte De Sécurité sur Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160

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

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
    2014-08-19
  • Date de publication de l'événement
    2014-08-19
  • 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_20140819.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: maquet venous bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160 the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice (fsn) concerning bubble trap vbt 160 and custom tubing sets containing the venous bubble trap vbt 160 manufactured by maquet cardiopulmonary ag. the following products are affected: venous bubble trap; vbt 160 (sterile single product) venous bubble trap; vbt 160 u (unsterile single product) custom tubing sets containing the vbi 160: bejbeo-vbt (bioline coating) custom tubing sets containing the vbt 160: bo-vbt (softlinf coating) the manufacturer received complaints from several customers who reported that during use, the venous bubble trap (vbt) draws air into the system. internal investigation by the manufacturer confirmed the customer reports and it was determined that a manufacturing defect in the production of the bubble trap is responsible for the intrusion of air into the system during use. as the main function of the vbt is to remove air from the system during use, the manufacturer considers this defect to present an unacceptable increased level of risk for the patient. if unaddressed, this could result in air entering the circulatory system of the patient and causing severe injury and the possibility of death. the manufacturer has received no reports that the defect present in the vbt has resulted in a serious injury or death to any patient. users of the affected products were advised to take the actions mentioned in the fsn. for details, please refer to mhra website: http://www.Mhra.Gov.Uk/home/groups/fsn/documents/fieldsafetynotice/con445987.Pdf if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 august 2014.

Device

Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Maquet Venous Bubble Trap VBT 160 and Custom Tubing Sets containing the Venous Bubble Trap VBT 160
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG