Events

Alerte De Sécurité sur Hemodialysis Machine Technical Name: ANVISA Registration Number: 80136990498 Hazard Class: III Affected Model: Dialog + and Dialog + HDF online (710200C, 7102072, 7105005 and 710500C)

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 Laboratórios B. Braun S.A.; B. Braun Avitum AG.

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
    2181
  • Date
    2016-10-21
  • 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
    The mentioned bug has been fixed with Software Version 8.2B. All Dialog + dialysis equipment with 8.2A software and optional Adimea MUST be upgraded to software version 8.2B, so that until all Dialog + devices are upgraded to 8.2B software, the "timer / stop" function must not be used watch "and / or reminders should be monitored independently from the machine. #### Update of the field action: UPDATED ON 11/23/2017, the company presented the report of completion of the field action, with sending of necessary evidences and corrective actions.
  • Cause
    A software (sw) error was identified in dialog + dialysis equipment version 8.2a that affects the timer / stop watch timer function. this function serves only as a user support to remind you of an action that should be taken by the user. this fault occurs only in sw 8.2a and only if used in conjunction with the adimea option. under certain conditions, and in rare episodes, the warning triggered to remind the user is restarted / changed by the machine without any human action. the user may be unaware that the notice has been modified.
  • Action
    Field Action Code AC / 03/2016 triggered under the responsibility of the company Laboratorios B. Braun SA Company will make correction in the field.

Device

Hemodialysis Machine Technical Name: ANVISA Registration Number: 80136990498 Hazard Class: III Af...

Manufacturer

Laboratórios B. Braun S.A.; B. Braun Avitum AG