Events

Alerte De Sécurité sur HOMECHOICE FOR DIALISE PERITONEAL BAXTER - Pack containing 01 System for Dialysis Peritoneal, model Homechoice, brand Baxter.

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
    685
  • Date
    2003-01-13
  • 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
    Although the company claims to have no reported patient harm associated with this occurrence, Baxter calls for careful monitoring of patients with low infusion volume before making clinical decisions based on the volume of ultrafiltrate shown through the HomeChoice System display. To monitor the fluid balance of the HomeChoice System when using very low filtrate volumes, the physician should rely on a physical examination of the patient. In addition, the volume of ultrafiltrate indicated by the HomeChoice System should be checked in order to make any necessary adjustment to the therapy in order to maintain the patient's dry weight. 02/17/2003 - The Tecnovigilâcia / ANVISA unit is checking the information provided by the company, regarding the technical procedures of the modifications with the customers.
  • Cause
    The company baxter hospitalar ltda informs about the use of the homechoice system, considering the latest version of the software 8.51, initially released in june 2002. this notice aims to notify doctors about the possibility of low volumes of ultrafiltrate when using low volume mode in automatic peritoneal dialysis (apd) therapy. under the conditions of use of low volume mode (infusion volume less than 200 ml), the equipment has a lower drained volume than the actual one. thus, if the physician considers only the volume indicated by the equipment may take improper conduct, increasing the ultrafiltration. such a measure may favor volume depletion for the patient. therefore, it is recommended that the conduct be based on physical examination of the patient, especially considering body weight and blood pressure.
  • Action
    Baxter Hospitalar Ltda, an affiliate of Baxter Healthcare Corporation in Brazil, hereby informs that it is sending the statement to the professionals / clinics that use the HomeChoice Peritoneal Dialysis System, as well as to its Home Care Coordinators. This release brings important information and aims to reduce any possibility of volume depletion during therapy with the HomeChoice System.

Device

HOMECHOICE FOR DIALISE PERITONEAL BAXTER - Pack containing 01 System for Dialysis Peritoneal, mod...

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA