Events

Alerte De Sécurité sur Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 710207E), registration 80136990498, risk class III, various series (SEE ANNEX).

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. Endereço; 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
    1825
  • Date
    2016-02-15
  • 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
    Reinforce the need for users NOT to use the hand-held level regulator in therapy and DO NOT perform any SN / CO single puncture therapy before certifying the perfect operation of the Dialog + SW 9.xx manual level regulator.
  • Cause
    By means of investigations by the registry holder, b. braun s / a, the possibility of reversing the positioning of the tubes between the valve block of the level regulator system and the diaphragm pump was identified. this occurs during any technical intervention or maintenance measures if the functionality of this level regulator system is not properly tested as required in the service manual. this can occur during any repair or maintenance activity where it is necessary to disconnect and reconnect the tubes, which results in reversing the function of the manual level control system.
  • Action
    Action code AC / 03/2015. Elaboration of Message Letter with Security Alert dated 04/4/2015 and delivery to each client involved //// Receipt of Receipt Confirmations of the Message Letter //// Correction in the field for the applicable cases through Correction of parts.

Device

Hemodialysis Machine, Dialog + and Dialog + HDF models online (7102005, 7102072, 710200C and 7102...

Manufacturer

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