Events

Avis De Sécurité sur HomeChoice/HomeChoice PRO Automated PD System

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Baxter Healthcare SA.

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
  • Numéro de l'événement
    SN2014(11)
  • Date
    2014-03-14
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/homechoice-homechoice-pro-automated-pd-system&id=baccf925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    Baxter healthcare is issuing a field safety notice (fsn) to inform users of the homechoice/homechoice pro systems of an additional warning to be included in the device product labeling. the warning relates to unintended increased intraperitoneal volume (iipv) in specific patient populations using peritoneal dialysis therapy.
  • Action
    1. Follow the manufacturer’s recommendations in the attached FSN. A copy of the FSN (and warning instructions) should be kept with your HomeChoice user manual. 2. Ensure that relevant personnel, in particular home patients, receive a copy of the attached FSN and are made aware of the information contained in the FSN and additional warning instructions.  3. If you have distributed the devices to other healthcare professionals or organisations, please forward this notice accordingly.

Device

HomeChoice/HomeChoice PRO Automated PD System

Manufacturer

Baxter Healthcare SA