Events

Alerte De Sécurité sur MultiFiltrate devices using software version 5.2

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Fresenius Medical Care AG & Co.

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
    2013-09-17
  • Date de publication de l'événement
    2013-09-17
  • 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_20130917.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: fresenius medical care multifiltrate devices using software version 5.2 the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning all multifiltrate devices using software version 5.2 manufactured by fresenius medical care ag & co. kgaa. the manufacturer has become aware of a software error when using the substitution bolus function during a continuous renal replacement therapy (crrt) treatment. in one case the substitution bolus unintentionally did not stop after 100 ml. in the worst case, a started substitution bolus is not controlled and automatically stopped by the machine and continues until manually stopped by the user. this situation can lead to severe volume overload and subsequently cause a serious health deterioration or even death. the manufacturer will provide the users with software update as soon as possible. meanwhile, users are strongly recommended to stop using the substitution bolus functionality. in case a fluid bolus is required during crrt, it is recommended that users should use the same process as applied in non-crrt treated patients, e.G. direct infusion of a suitable infusion solution. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con314890 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2013.

Device

MultiFiltrate devices using software version 5.2
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Medical Care MultiFiltrate devices using software version 5.2
  • Manufacturer
    Fresenius Medical Care AG & Co

Manufacturer

Fresenius Medical Care AG & Co