Events

Field Safety Notices about HomeChoice APD System, HomeChoice PRO APD 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
  • Date
    2014-12-11
  • Event Date Posted
    2014-04-12
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/12/04/vazno-obavestenje-o-medicinskim-sredstvima-homechoice-apd-system-i-homechoice-pro-apd-system-2/
  • 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
    As part of the safety corrective action, the manufacturer modifies the labeling method of the medical device, as well as supplementing the instructions for use, adding warnings and precautions not previously stated. this safety-corrective measure was not initiated because of an increase in the incidence of adverse drug reactions, but as a result of increased patient safety concerns. homechoice is not intended to be a substitute for a nephrologist in monitoring the patient's overall condition. using this device without monitoring the patient's condition may result in serious injury or death.

Device

HomeChoice APD System, HomeChoice PRO APD System

Manufacturer

BAXTER HEALTHCARE CORPORATION