Events

Alerte De Sécurité sur HomeChoice Automated Peritoneal Dialysis system(Patient At-Home Guide)

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_20130410c.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(patient at-home guide) medical device manufacturer, baxter healthcare, has issued a safety alert letter to customers to inform them of the best practice for properly managing a planned or emergency disconnect from their homechoice automated peritoneal dialysis (pd) system(product code 5c4474). the homechoice patient at-home guide (part number 071964016) describes using a flexicap or opticap for high dose therapy (optichoice therapy) or for an emergency disconnect. however, the flexicap or opticap are not available in hong kong. if patients disconnect during therapy and do not reconnect using new supplies, there may be a possible of contamination of the patient line, which may lead to peritonitis. baxter advises patients that if they need to disconnect from their therapy before it is completed, they should end the therapy and then restart the therapy using all new supplies (such as solution bags and the disposable set). 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(Patient At-Home Guide)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter HomeChoice Automated Peritoneal Dialysis system (Patient At-Home Guide)
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare