Events

Alerte De Sécurité sur HomeChoice Pro Automated Peritoneal Dialysis System

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
    2013-11-04
  • Date de publication de l'événement
    2013-11-04
  • 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_20131104a.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 pro automated peritoneal dialysis system the australia therapeutic goods administration (tga) has issued a medical device safety alert concerning homechoice pro automated peritoneal dialysis (apd) system manufactured by baxter healthcare. products with product code r5c8320 and the serial numbers 300905, 300882, 300928, 300889 are affected. there is a potential issue with the occluder assembly of homechoice pro devices. the blade of the occluder assembly is covered with a rubber boot. the occluder blade clamps the solution lines if a power failure occurs or when the cycler is off. this prevents uncontrolled solution delivery to the patient. an occluder failure will cause an unrecoverable slow flow/no flow alarm or an unrecoverable system error. the device will fail in a safe position and prevent solution from being delivered to the patient. baxter is informing the affected hospitals of the issue. hospitals will either notify affected patients or baxter will contact patients via homecare and arrange to swap the affected machines. baxter is also advising patients to perform manual peritoneal dialysis to continue therapy if there is an unrecoverable failure. according to the local supplier, the affected products were not distributed in hong kong. for details, please visit the following tga website: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2013-rn-01117-1 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 4 november 2013.

Device

HomeChoice Pro Automated Peritoneal Dialysis System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter HomeChoice Pro Automated Peritoneal Dialysis System
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare