Events

Avis De Sécurité sur 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.

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
    2016-01-19
  • Date de publication de l'événement
    2016-03-02
  • Pays de l'événement
    Serbia
  • Source de l'événement
    ALIMSA
  • URL de la source de l'événement
    https://www.alims.gov.rs/latin/2016/02/03/vazno-obavestenje-o-medicinskom-sredstvu-homechoice-pro-apd-system-aparat-za-peritonealnu-dijalizu-kataloski-broj-r5c8320/
  • 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
    An integral part of the homechoice pro is an air (pneumatic) pump.Certain sounds like buzzing, whistling, clicking and venting (air release) are expected and common during the operation of the appliance.Amplifying these sounds at certain stages of the camera's operation is also common.However, if any of these sounds increases significantly or a new sound occurs that was not previously heard during the operation of the appliance, the user should inform his doctor and / or sister or the manufacturer's representative.

Device

HomeChoice PRO APD System

Manufacturer

BAXTER HEALTHCARE