Events

Alerte De Sécurité sur CDI™ 500 Blood Parameter Monitoring System

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
    2012-03-09
  • 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_20120310b.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
    Field safety notice: terumo cdi™ 500 blood parameter monitoring system medical device manufacturer, terumo cardiovascular systems corporation, has issued a field safety notice concerning cdi™ 500 blood parameter monitoring system. in a recent review of in-house service procedures for the cdi™ 500 blood parameter monitoring system, terumo cardiovascular systems (terumo cvs) determined that replacement of the batteries should be considered “routine maintenance”. currently, system batteries that are 10 years old or older will be replaced by service technicians when a system is sent to terumo cvs for service. the current operator’s manual for the cdi 500 system does not list any routine maintenance procedures for the system. therefore, some systems may be relying on system batteries beyond their useful life. in this case, error codes may appear, and the system is at risk of losing information. there have been no reports of patient injury as a result of this issue. terumo cvs is now revising the operator’s manual for the cdi 500 system to remind operators to replace the system batteries every 10 years. according to the local supplier, affected devices have been distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions.

Device

CDI™ 500 Blood Parameter Monitoring System

Manufacturer

Terumo Cardiovascular Systems Corporation