Events

Alerte De Sécurité sur Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000

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
    2012-11-02
  • Date de publication de l'événement
    2012-11-02
  • 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_20121102b.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 arterial and cardioplegia monitor for sarns modular perfusion system 8000 medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has initiated a field safety corrective action concerning the arterial and cardioplegia monitors for sarns modular perfusion system 8000. terumo cvs has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the sarns modular perfusion system 8000. the malfunctions can be broadly categorized as follows: monitor power malfunctions inability to measure pressure inaccurate pressure readings and/or false pressure alarms terumo cvs’ initial investigation has determined that while the operator’s manual for the sarns system 8000 provides instruction on how to respond to the malfunctions, the manufacturer believes the instruction can be clarified for responding to false alarms. there are no known reports of patient injury as a result of these issues. furthermore, the manufacturer is notifying all affecteds users of the possibility of malfunction and reminding them to review the appropriate sections of the operator’s manual, and providing an addendum to the operator’s manual to clarify instruction on how to respond to a false alarm. 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 2 november 2012.

Device

Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo Arterial and Cardioplegia Monitor for Sarns Modular Perfusion System 8000
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation