Events

Alerte Ou Avis De Sécurité sur Protect-A-Line extension set

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Vygon.

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
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2013/056
  • Numéro de l'événement
    CON297509
  • Date
    2013-07-25
  • Date de publication de l'événement
    2013-07-25
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON297509?tabName=allTabs
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
  • Cause
    Risk of false occlusion alarms and interruption to therapy. this is due to a new anti-syphon valve supplied with the sets, which has a higher opening pressure and may require adjustment of infusion pump occlusion alarm settings to avoid false occlusion alarms. vygon are validating a further modification to the anti-syphon valves to marginally reduce the required opening pressure and will supply sets incorporating these once verification has been completed.
  • Action
    Ensure that all members of staff are made aware of the recommended actions in the manufacturer’s Field Safety Notice. As some hospitals may be using both types of anti-syphon valve, be vigilant if you alter your infusion pump occlusion alarm settings for the new valves.  Make sure you do not have the previous design of valve (which operates at a lower opening pressure) on the line. The product codes for these previous devices are: 0832.01R, 0832.04R and 0832.211R.

Device

Protect-A-Line extension set
  • Modèle / numéro de série
  • Description du dispositif
    Protect-A-Line extension set. Product codes: 0832.01, 0832.04 and 0832.211. NHS Supply Chain codes (England only): FSB128, FSB124 and FSB0146.
  • Manufacturer
    Vygon

Manufacturer

Vygon