Events

Field Safety Notices about HomeChoice 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
  • Event Date Posted
    2014-01-14
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2014/01/14/vazno-obavestenje-o-medicinskim-sredstvima-homechoice-apd-system-i-omechoice-pro-apd-system/
  • 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
    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