Alerte De Sécurité sur HomeChoice (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 (Hong Kong).

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
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • 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
    Recall of automated peritoneal dialysis system the department of health (dh) received a notification from baxter healthcare limited (hong kong) (baxter) this afternoon (august 11) that it would organise with customers the return and replacement of an automated peritoneal dialysis system, homechoice (product code: 5c4474). baxter explained that the arrangement was necessary because the required final tests and calibration of the product model had not been performed, a spokesman for the department said. through network searching, the dh also noticed that the us food and drug administration (fda) had actually issued an alert earlier on this year concerning reports of serious injuries and at least one death linked to increased intraperitoneal volume (iipv) associated with the use of the same model. iipv can cause serious breathing and heart problems which can result in serious injury or death. in addition, children and nonverbal patients may be at increased risk because of their smaller abdominal cavities or inability to communicate. according to baxter, at least 186 homechoice devices had been affected in hong kong. so far, the dh and baxter have not received any report of adverse events related to this issue. taking into account the information available, dh is concerned with possible safety, efficacy and quality of the product, he said. while seeking further clarification from fda and the baxter of two events, dh in fact instructed baxter to recall and replace the device concerned. "patients using the device are urged to contact their attending doctors immediately," the spokesman said. "as an interim, clinicians are advised to balance the risks and benefits to continued use of these devices by their patients versus other forms of dialysis therapy. "they should also review the prescription settings for patients who continue to use these devices," he said. baxter's local supplier has set up a hotline, 6113 1063, for public enquires. the dh will closely monitor the progress of the recall. ends/wednesday, 11 august 2010.