Events

Avis De Sécurité sur Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx

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

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(08)
  • Date
    2014-02-27
  • 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=/applix-smart-applix-vision-nutrition-pumps-serial-numbers-from-1998xxxx-to-2010xxx&id=dd77f825-9782-6eee-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
    Fresenius kabi received an increasing number of complaints from the market about non-detected occlusions. as one possible influencing factor, a defective ball bearing was identified, potentially leading to a shift in the flow rate calibration values. fresenius kabi has been unable to locate all affected pumps that require an upgrade.
  • Action
    The IMB advises that users:  (1) The IMB recommends that users forward this safety notice to all those who need to be aware of this action within your organisation, including those who maintain pumps and to any other persons/organisations where these devices have been transferred.  (2) Identify the location of all affected pumps.  (3) If you / your institution have any affected pumps, please follow the manufacturer’s recommendations as outlined in the attached field safety notice and contact Fresenius Kabi.

Device

Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Modèle / numéro de série
  • Description du dispositif
    Applix Smart & Applix Vision Nutrition Pumps Serial numbers from 1998xxxx to 2010xxx
  • Manufacturer
    Fresenius Kabi Limited

Manufacturer

Fresenius Kabi Limited