Events

Avis De Sécurité sur HomeChoice APD System

Selon ALIMS (Agencija za lekove i medicinska sredstva), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Serbia qui a été fabriqué par Baxter Healthcare Corporation.

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 de publication de l'événement
    2014-01-14
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2014/01/14/vazno-obavestenje-o-medicinskim-sredstvima-homechoice-apd-system-i-omechoice-pro-apd-system/
  • Notes / Alertes
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), 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 Serbia.
  • Notes supplémentaires dans les données
  • Cause
    Clinicians using homechoice to treat patients diagnosed with end-stage kidney disease with ascites should be aware that homechoice will attempt to drain the patient to discharge at the beginning of therapy ("initial extract"). with homechoice 10.210 software, the user was allowed to stop the active initial spill and then bypass it. with homechoice 10.4 software, this functionality has been removed. drainage to discharge in patients with ascites-diagnosed comorbidity is associated with an increased risk of hypotension and serious impairment of their hemodynamic status.

Device

HomeChoice APD System

Manufacturer

Baxter Healthcare Corporation