Events

Alerte De Sécurité sur HOMECHOICE FOR AUTOMATED PERITONEAL DIALISE. HOMECHOICE SYSTEM - VERSION 8.51

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda.

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
  • ID de l'événement
    679
  • Date
    2002-10-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    BRAZIL - 29.10.2002 - The automated Peritoneal Dialysis System for Homechoice and Homechoice PRO is registered in Brazil under the number 10068390123. According to company information (letter dated September 27, 2002), there are no reports of physical damage associated with this situation. Baxter is sending important information to be observed with the Homechoice System, software version 8.51, launched in June 2002 to notify the clinical and patient staff of home-based DPA-directed actions to reduce the likelihood of a possible excessive infusion of volume , which could occur under certain conditions.
  • Cause
    "it was found that stopping or advancing a manual drainage during an infusion phase could result in excessive infusion of volume. therefore, if the patient requires manual drainage during the filling phase, it is important that drainage is performed without interruption, with purpose of preventing excessive volume infusion. these instructions apply only to versions 8.51 and 8.52 of the homechoice system software.
  • Action
    Routing of safety information to customers about the Homechoice System. Proposal for corrective actions (BAXTER): - Send letters with information to affected patients and to coordinators DE Home Care; -Send revised instructions from the patient manual to Homechoice users, help reports, and an operator's manual. -Correct the possibility of excessive infusion of volume with the next version of the software. For further information please contact us on 0800 12 55 22, option 1.

Device

HOMECHOICE FOR AUTOMATED PERITONEAL DIALISE. HOMECHOICE SYSTEM - VERSION 8.51

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA