Events

Avis De Sécurité sur ARTIS/EVOSYS DIALYSIS SYSTEM

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 Baxter.

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
    2016-07-20
  • 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
    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
  • Modèle / numéro de série
  • Manufacturer
    Baxter

Manufacturer

Baxter