Events

Field Safety Notices about Dialog Dialysis Machines

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
    2016-06-21
  • 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 that a limited number of flanges assembled into bicarbonate and end conductivity cells showed hairline cracks. these flanges have been limited to three batches manufactured by our supplier. this issue affects the above mentioned dialog+ machines and dialog+/dialog/dialog advanced machines where potentially affected conductivity sensors have been exchanged. if such hairline crack occurs, this can potentially lead to a leakage which might result in a balance deviation. the kind of the potential balance deviation depends on whether a dialog machine is equipped with dialysis fluid (df) filter(s) or not. .

Device

Dialog Dialysis Machines

Manufacturer

B Braun