Events

Notificaciones De Seguridad De Campo acerca de SENSATION PLUS® 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit

Según Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Slovenia que fue producido por Getinge.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Field Safety Notice
  • País del evento
    Slovenia
  • Fuente del evento
    AMPMDRS
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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
  • Modelo / Serial
    3000043375
  • Manufacturer
    Getinge

Manufacturer

Getinge
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    AMPMDRS