Events

Field Safety Notices about ARTIS/EVOSYS DIALYSIS SYSTEM

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 Baxter.

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
    2016-07-20
  • 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
    Baxter distributed an f sn (ref. annex 1 fsn fa—2014—010) in december 2014 to advise the user of the possibility that foam may have formed in the venous blood line when the extracorporeal circuit was primed using on—line priming. the f sn provided additional information on how to perform priming in case the specific dialyzer in use generates foam in the venous chamber. the number of reports of foam in the venous chamber significantly decreased with the application offsn fa-2014—010 recommendation as a collateral effect of the same problem, i.E. residual air and foam after priming, it has been observed an increased probability of air alarms occurrence. it has to be clarified that air alarm is not a risk in itself and is intended to prevent infusion of air which might be dangerous to the patient. this alarm stops the blood pump and interrupts the treatment until resolution by the user. in some cases it was reported that a few minutes after resolving an occurrence of air alarm and restarting the blood pump the patient experienced symptoms commonly repofied as hypotension. this typically followed a prolonged blood pump stop associated to a problematic air alarm troubleshooting.

Device

ARTIS/EVOSYS DIALYSIS SYSTEM
  • Model / Serial
  • Manufacturer
    Baxter

Manufacturer

Baxter