Events

Field Safety Notices about Dialog+ Dialysis Machines with Software 8.2A in combination with Option Adimea

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by B. Braun.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2016-10-10
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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

Manufacturer

B. Braun