Events

Alerte De Sécurité sur HomeChoice Automated Peritoneal Dialysis Systems (product code: 5C4474)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Baxter Healthcare Limited.

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
    2013-04-10
  • 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/press_20130410.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
    Press release
  • Cause
    Safety alert on automated peritoneal dialysis system the department of health (dh) today (april 10) drew the public's attention to a safety alert issued by a local medical device supplier, baxter healthcare limited (baxter), regarding the integrity of the ac power cords of its homechoice automated peritoneal dialysis systems (product code: 5c4474). the dh received a notification from baxter that the company was aware of a modification carried out to the ac power cords used on the device which involved fitting of a local ac plug that could affect the integrity of the ac power cord in use. according to baxter, although all power cords for the device currently being used in hong kong fulfilled the local standards and have passed relevant electrical safety tests before use, the overall integrity of these power cords was uncertain and may lead to two potential risks to users. firstly, the device may fail to function and the dialysis session will be delayed. secondly, there is a potential for an electrical fire or shock. however, the possibility of the occurrence of these risks is very low. a dh spokesman said, "the dh's preliminary enquiries with baxter revealed that some 600 devices have been distributed to public and private hospitals and home users in hong kong. baxter will arrange replacement of the ac power cords for customers during their next on-site maintenance of the equipment." baxter has set up a hotline (9160 3535), for public enquiries. "so far, there is no relevant report of adverse incidents related to the use of this device in hong kong," the spokesman added. the dh has informed public and private hospitals and relevant medical associations about the alert and shall continue to liaise with baxter on the follow-up actions. ends.

Device

HomeChoice Automated Peritoneal Dialysis Systems (product code: 5C4474)
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety alert on automated peritoneal dialysis system
  • Manufacturer
    Baxter Healthcare Limited

Manufacturer

Baxter Healthcare Limited