Events

Alerte De Sécurité sur Advanced Perfusion System 1, Battery

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_20120703c.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, battery 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 multiple reports regarding battery capacity issues in which the terumo® advanced perfusion system 1 displayed some or all of the following symptoms: the system displayed false information, indicating battery capacity (i.E. hours/minutes remaining) when the batteries have little or no remaining capacity the system unexpectedly shut down without warning when running on battery power batteries were completely depleted batteries did not retain their charge as intended terumo cvs' investigation determined that failure to properly charge and maintain the terumo system 1 batteries can cause the 'estimated battery time remaining' indicator (on the power sub tab of the ccm) to display more battery time than is actually available the potential harm is exacerbated if the user believes the batteries are fully charged because the system falsely over-reports the available battery time. there have been no reports of patient injury as a result of this issue. the manufacturer is developing a field correction to prevent the ‘estimated battery time remaining’ indicator from falsely over-reporting available battery time. 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, Battery
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Battery
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems