Events

Field Safety Notices about HomeChoice APD System, HomeChoice PRO System

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by BAXTER HEALTHCARE CORPORATION.

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
  • Event Date Posted
    2014-05-05
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/05/05/azno-obavestenje-o-medicinskim-sredstvima/
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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