Events

Alerte De Sécurité sur Advanced Perfusion System 1

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
    2012-01-13
  • 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_20120112.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
    [13 january 2012] field safety notice: terumo® advanced perfusion system 1 medical device manufacturer, terumo® cardiovascular systems corporation, has issued a field safety notice on the use of unauthorized cable for terumo® advanced perfusion system 1. the manufacturer is aware of some users operating a terumo® advanced perfusion system 1 with a modified cable to connect the system to an occluder for the sarns™ modular perfusion system 8000. the cable is not specified for use with terumo® system 1 and its use in this manner constitutes an off-label use. the modified cable is not compliant with terumo® system 1 specifications and its use may result in hazardous conditions such as easy dislodgement from the system base resulting in loss of the occluder’s function. it may cause the system to lose electro-magnetic interference protection or create a minor shock hazard in the event of an internal short/failure within the occluder system components. according to the local supplier, the affected product is not distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation