Events

Alerte De Sécurité sur Artis 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
    2017-03-06
  • Date de publication de l'événement
    2017-03-06
  • 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_20170306a.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 healthcare artis dialysis system medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its artis dialysis system [product code: 110635 (artis 230v), 115323 (artis 230v physio, and 115962 (artis 230v physio i); software version: 8.09, 8.15, 8.33 and 8.52]. the manufacturer is initiating a field action to update the software version for the above models and software version of artis dialysis system in hong kong. the current version allows for the possibility of resetting and continuing patient treatment without following the instructions for addressing alarm #642, “arterial chamber: level adjustment required.” this will subsequently deactivate the alarm for the remaining treatment time. the reset that follows will predispose patient to venous air embolism. the new software versions prevent the possibility of continuing the treatment without following the instructions for addressing alarm #642, as written in the operator’s manual. deactivation of the alarm #642 for the remaining treatment time following a reset will predispose patient to venous air embolism. there were no adverse events and complaints reported in hong kong that potentially related to this issue. operator may continue to safely use the affected artis dialysis systems while utilizing additional vigilance to adhere to the instructions for use for addressing alarm #642, as documented in the operator’s manual until the software upgrade is completed. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 6 march 2017.

Device

Artis Dialysis System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Artis Dialysis System
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare