Events

Alerte De Sécurité sur HDF On-line

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Medica S.p.A.

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
    2014-02-18
  • Date de publication de l'événement
    2014-02-18
  • 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_20140218.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: medica hdf on-line the medicines and healthcare products regulatory agency (mhra), united kingdom posted a field safety notice concerning the haemodiafiltration device, “hdf on-line” [product code: m03831] manufactured by medica s.P.A. the affected products are identified by the following batch numbers: pv13/0352, pv13/0398, pv13/0401, pv13/0440, pv13/0450, pv13/0457 pv13/0458, pv13/0469, pv13/0504, pv13/0508, pv13/0517, pv13/0518, pv13/0519, pv13/0536, pv13/0538. the manufacturer has become aware that some hdf on-line units may have loose connections between the ultra-filter headers and the tubings. this may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment. some hdf on-line units may have loose connections between the ultra-filter headers and the tubings which may lead to a fluid loss from the device, occurring during the priming of the line or during patient treatment. according to the manufacturer, if fluid loss from a connector occurs during treatment and it is not detected, this event may cause a fluid imbalance in the patient, with the risk of excessive weight loss (hypovolemia). another potential risk (this has never happened to-date and the probability of occurrence is remote) is the impairment of the sterile barrier which is ensured by the proper tightness of the connections, with the consequent need for medical intervention to prevent further complications. the manufacturer advises all affected users to check the connections of the hdf on-line device are tightly screwed before and after use. for details, please refer to the following link:http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con377619 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2014.

Device

HDF On-line
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medica HDF On-line
  • Manufacturer
    Medica S.p.A

Manufacturer

Medica S.p.A