Events

Alerte De Sécurité sur advanced perfusion system 1

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.

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
    2014-06-20
  • Date de publication de l'événement
    2014-06-20
  • 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_20140620.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 medical device manufacturer, terumo, has issued a field safety notice concerning advanced perfusion system 1 with the following details: catalogue no.: 801763 (base for terumo advanced perfusion system 1, 100/120v); 801764 (base for terumo advanced perfusion system 1, 220/240v) serial no.: all dates of distribution: 23 aug 2002 through current through internal assessment, the manufacturer has identified opportunities to improve patient safety by clarifying instructions in the operators manual for the terumo advanced perfusion system 1. updates to the operators manual will make the directions easier to follow and provide more accurate performance ranges that align with device operation. the manufacturer is providing updated instructions to four sections of the operators manual, as the following addenda: terumo advanced perfusion system 1 pressure module terumo advanced perfusion system 1 automatic pump direction change terumo advanced perfusion system 1 centrifugal control unit terumo advanced perfusion system 1 modules according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 20 jun 2014.

Device

advanced perfusion system 1
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Advanced Perfusion System 1
  • Manufacturer
    Terumo

Manufacturer

Terumo