Events

Alerte De Sécurité sur Advanced Perfusion System 1, Central Control Monitor

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
    2012-07-03
  • Date de publication de l'événement
    2012-07-03
  • 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_20120703b.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, central control monitor medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumo® advanced perfusion system 1. the manufacturer has received reports of the central control monitor (ccm) for terumo advanced perfusion system 1 losing partial or full functionality. symptoms that have been associated with a malfunctioning ccm include: full or partial loss of display; loss of control functions; or an inability to distinguish various status, alert, or alarm conditions. in one report, the ccm emitted smoke. their preliminary investigation found the failures were due to design or supplier workmanship issues. the probability of patient injury caused by this malfunction is low because all the primary functions and controls on the ccm can be maintained through the terumo system 1's local controls. there have been no reports of patient injury as a result of this issue. the manufacturer is providing an addendum to the operator's manual for terumo system 1 with instruction on what to do in the event of a ccm 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 3 july 2012.

Device

Advanced Perfusion System 1, Central Control Monitor
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Central Control Monitor
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems