Events

Alerte De Sécurité sur Advanced Perfusion System 1, Roller Pump

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_20120703d.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, roller pump medical device manufacturer, terumo® cardiovascular systems (cvs) corporation, has issued an urgent field safety notice concerning terumor advanced perfusion system 1. the manufacturer has received reports of various roller pump malfunctions of the terumo® advanced perfusion system 1 that could result in the inability to use the pump and require the user to replace it with back-up equipment. the malfunctions included: unplanned pump stop,changes in pump speed and occlusion malfunctions. there are no known reports of serious patient injury as a result of these issues. terumo cvs' evaluation and/or initial investigation has determined that there are likely multiple root causes for the failures. it has initiated further investigation to determine exact root cause. as an interim precaution, the manufacturer is informing affecting users the risks associated with these failures, reminding them of the relevant instructions in the operator's manual, and providing an addendum to the operator's manual with additional instructions to be used during set-up to prevent occlusion malfunctions. 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, Roller Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo® Advanced Perfusion System 1, Roller Pump
  • Manufacturer
    Terumo® Cardiovascular Systems

Manufacturer

Terumo® Cardiovascular Systems