Events

Alerte De Sécurité sur advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000

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
    2012-06-22
  • Date de publication de l'événement
    2012-06-22
  • 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_20120622.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 advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion system 9000 medical device manufacturer, terumo cardiovascular systems (cvs) corporations, has issued an urgent field safety notice concerning terumo advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ perfusion system 9000. the manufacturer has received multiple reports of false alarms generated by the air bubble detection system used with perfusion system of the above models. it will possibly result in temporary interruption of arterial blood flow, air entrainment in the system, or the need to continue the case with a disabled air sensor. there have been no reports of patient injury as a result of this failure. their investigation determined that prior corrective actions on the sensor (in 2007 and 2010) did not fully eliminate the possibility for malfunction. therefore, terumo cvs has amended the operator’s manuals for its heart-lung machines to alert all users of the potential for a malfunction of the air bubble detection system and to reinforce the mitigation procedures in the event of a malfunction. according to the local supplier, the affected devices were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 june 2012.

Device

advanced perfusion system 1, sarns™ modular perfusion system 8000 and sarns™ modular perfusion sy...
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1, Sarns™ Modular Perfusion System 8000 and Sarns™ Modular Perfusion System 9000
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems