Events

Alerte De Sécurité sur sleep safe sets

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.

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
    2013-12-03
  • Date de publication de l'événement
    2013-12-03
  • 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_20131203.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 sleep safe sets the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) issued a medical device safety alert concerning sleep safe sets manufactured by fresenius medical care. the affected article numbers are 5016921 sleep safe set, 5016931 sleep safe set plus, 5017391 sleep safe set paed, and 5017491 sleep safe set plus (japanese version). furthermore, the affected batch numbers of 5016931 sleep safe set plus are ugs231, uis031, uis032, and uks091. during the continuous monitoring of the sleep safe tubing systems on the market, the manufacturer has become aware of possible leakages caused from a small hole at the patient connector which might not be detected by visual inspection. the sleep safe cycler cannot detect such a leakage. therefore, there is a potential risk of infection for the patient, e.G. the development of peritonitis. so far, no case of peritonitis has been observed due to such a leakage. the manufacturer recommends users to stop using the affected product batches and they will organize the replacement of the affected sleep safe sets. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con341232 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 3 december 2013.

Device

sleep safe sets
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Medical Care sleep safe sets
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care