Events

Avis De Sécurité sur HomeChoice APD System, HomeChoice PRO APD 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
    2013-01-21
  • Date de publication de l'événement
    2013-08-02
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2013/02/08/vazno-obavestenje-o-medicinskim-sredstvima-homechoice-apd-system-i-homechoice-pro-apd-system/
  • 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
    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