Events

Alerte De Sécurité sur Haemodialysis bloodline for 4008 dialysis machine

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
    2015-04-15
  • Date de publication de l'événement
    2015-04-15
  • 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_20150415c.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 haemodialysis bloodline for 4008 dialysis machine medical device manufacturer, fresenius medical care, has issued a medical device safety alert concerning haemodialysis bloodline for 4008 dialysis machine [article numbers: i) ap16661 av-set b dt inf-e; ii) ap16843 av-set dt-e. batch numbers: i) vhc231, vhc231a, vic252, vkc262, vlc202, vmc261; ii) vhc012, vic011, vic033, vic192, vic251, vic263, vic291, vkc042, vkc071, vkc094, vkc301, vlc032, vmc041, vmc172, vmc193, wac114, wac143, wac163, wac191, wac221, wac312]. the manufacturer has observed an increased likelihood of blood leakage between dialyzer connector and tubing during post marketing surveillance. it has been determined that a supplied material used in the dialyzer connector manufactured between august 2014 and march 2015 is causing a weak seal between the connector and tubing. the manufacturer has corrected this issue with an alternate approved and validated connector material. users are advised to stop using the affected products immediately. product recall is ongoing. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 april 2015.

Device

Haemodialysis bloodline for 4008 dialysis machine
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Fresenius Medical Care Haemodialysis bloodline for 4008 dialysis machine
  • Manufacturer
    Fresenius Medical Care

Manufacturer

Fresenius Medical Care