Events

Alerte De Sécurité sur LIFE 18 apheresis 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 Miltenyi Biotec.

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
    2014-01-22
  • Date de publication de l'événement
    2014-01-22
  • 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_20140122.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: miltenyi biotec life 18 apheresis system the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning life 18 apheresis system, manufactured by miltenyi biotec. tests in laboratory have shown the possibility that under certain circumstances the life 18 apheresis unit will not interrupt the treatment and stop all pumps if a blood leak occurs in the tubing of the disk separator. according to the manufacturer, this type of a severe blood leak in the fluid path of the disk separator during a treatment has been observed for the first time in more than 30.000 treatments performed with the separator. the manufacturer is developing revised software which will be able to correct the gap in the blood leak detection of the life 18 apheresis unit. as an intermediate preventive action, the manufacturer advises users of the followings: make sure that the patient connected with the life 18 apheresis unit never remains unattended during the treatment. check for tubing set integrity regularly during the treatment. when the blood leak is detected, users should stop the treatment and replace the defective separator. for details, please refer to mhra website http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con362398 if you are in possession of the product, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

LIFE 18 apheresis system
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Miltenyi Biotec LIFE 18 apheresis system
  • Manufacturer
    Miltenyi Biotec

Manufacturer

Miltenyi Biotec