Events

Avis De Sécurité sur Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 Single, Sterile Over-pressure Safety Valve

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Terumo Cardiovascular Systems.

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
    2017-07-17
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    This field safety notice calls attention to a situation that may arise with the ln130b over-pressure safety valve (ops valve) within your terumo extracorporeal tubing set or the lh130 single, sterile ops valve, and recommends how to check to ensure the duckbill valve within the ops valve is patent and allows flow through the valve. the ln130b or lh130 ops valves are to prevent reversal of blood flow and the prevention of air embolism as well as limit excessive negative and positive pressure in the vent catheter. the ops valve allows for flow in only one direction (from the catheter in the heart to the cardiotomy reservoir). .

Device

Terumo Extracorporeal Tubing Sets involving the LN130B Over-pressure Safety Valve or the LH130 S...

Manufacturer

Terumo Cardiovascular Systems