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
    2013-01-21
  • Event Date Posted
    2013-08-02
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2013/02/08/vazno-obavestenje-o-medicinskim-sredstvima-homechoice-apd-system-i-homechoice-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
    Baxter healthcare, as part of a safety corrective measure, issued an important notice on a medical device to indicate the possible occurrence of elevated intraperitoneal volume (iipv), if total ultrafiltration (total uf) and minimum volume east (mdv%) are not properly programmed in tidal automatic peritoneal dialysis (tidal apd). iipv can lead to serious injuries or death due to: hernia of the abdominal wall or hernia of the diaphragm, then hydrothorax, heart failure, acute hypertension, pulmonary edema, decreased pulmonary function and pericardial effusion. children and patients who do not communicate are significantly more vulnerable because they are smaller and / or unable to indicate symptoms, by communication. other populations that are more vulnerable are critically ill patients and patients who are pulmonary or hemodynamically unstable.

Device

HomeChoice APD System, HomeChoice PRO APD System

Manufacturer

Baxter Healthcare Corporation