Events

Alerte De Sécurité sur HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)

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.

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
  • Date de publication de l'événement
    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/recalls_20130410b.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: baxter homechoice automated peritoneal dialysis system (ac power cord set) medical device manufacturer, baxter healthcare, has initiated a medical device field safety correction action concerning homechoice automated peritoneal dialysis (pd) system (product code 5c4474). following a recent review, baxter has become aware of a modification carried out to the ac power cords used on homechoice automated pd devices. the modification has involved fitting of a local ac plug which could affect the integrity of the ac power cord set in use. although all power cords for homechoice device currently using in hong kong fulfill the standard bs1363 and follow the guideline of hong kong electrical and mechanical services department, the overall integrity of these power cords is uncertain. it is baxter’s intention to replace it with an approved version power cord over the coming 12 months. there are two potential risks to the user. 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 to occur, which may result in burns or cardiac death in extremely rare case. baxter has already developed an approved power cord to suit multi-countries requirements with an integral plug for use on homechoice pd system. also, baxter technical service engineers will replace ac power cords for the homechoice device in the facility and patient’s home during the next onsite maintenance. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 april 2013.

Device

HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (AC Power Cord Set)
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare