Events

Avis De Sécurité sur SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit

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 Getinge.

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
  • 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
    During internal pressure (leak) testing of the sensation plus 8fr. 50cc, iabc, failures related to the tip seal leak were identified within the lot number listed above. this issue at the catheter tip seal could potentially cause a leak in the balloon and may lead to an interruption of therapy resulting in the need to replace the defective iabc with a new catheter. such occurrences could cause momentary hemodynamic instability in the patient, or potential complications related to vessel bleeding related to replacement of the iab catheter. to date, there have been no reports of serious injury. .

Device

SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit
  • Modèle / numéro de série
    3000043375
  • Manufacturer
    Getinge

Manufacturer

Getinge
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    AMPMDRS