Events

Avis De Sécurité sur Dialog+ Dialysis Machines with Software 8.2A in combination with Option Adimea

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par B. Braun.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Date
    2016-10-10
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    We became aware of a software error in software (sw) 8.2a of the dialog+ dialysis machine affecting the timer/stop watch function. this timer function only serves as a support to the user to remind him of an action that has to be taken by him. the failure occurs only in sw 8.2a and only in combination with option adimea. in certain conditions and on rare occasions the warning triggered to remind the user is reset by the machine without user interaction. the user might not be aware that the reminder was triggered at all. .

Device

Dialog+ Dialysis Machines with Software 8.2A in combination with Option Adimea
  • Modèle / numéro de série
  • Manufacturer
    B. Braun

Manufacturer

B. Braun