Events

Avis De Sécurité sur HomeChoice APD System, HomeChoice PRO 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
    2014-05-05
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2014/05/05/azno-obavestenje-o-medicinskim-sredstvima/
  • 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
    The manufacturer has given a notice accompanying the instruction manual for the "homechoice / homechoice pro" system, which provides specific instructions for patients if there is a suspected increased intraperitoneal volume ("iipv"), also known as "overfill". specifically, "iipv" is an inherent risk of peritoneal dialysis therapy. the condition is characterized by an unintended excess fluid in the peritoneal cavity that may become symptomatic, especially in high-risk population groups (infants, infants, young children and all patients with significant cardiac or pulmonary diseases). dialysate overfill (iipv) or insufficient dialysate leakage during "pd" therapy may lead to excess fluid in the abdomen of the patient followed by appropriate specific symptoms.

Device

HomeChoice APD System, HomeChoice PRO System

Manufacturer

BAXTER HEALTHCARE CORPORATION