Events

Alerte De Sécurité sur Advanced Perfusion System 1, Centrifugal 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.

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_20120703a.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, centrifugal system 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 since september 2008 of various malfunctions of the sarns™ centrifugal system for the terumo® advanced perfusion system 1 in which the user was unable to achieve or maintain the desired flow rate. their investigation revealed that a number of root causes contributed to the failures. the probability of the malfunction occurring in the affected population is rare – less than 0.00318% of uses. the manufacturer is creating an addendum to the operator's manual for the terumo system 1 centrifugal system which includes the following: updates the instructions for responding to drive motor failure. reinforces the recommendation to have back-up equipment for the centrifugal system available during cardiopulmonary bypass. recommends that users consider the use of a one-way valve to prevent retrograde flow in the arterial line of the cardiopulmonary bypass circuit. 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, Centrifugal System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Centrifugal System
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems