Notificaciones De Seguridad De Campo acerca de Ebb Complete Tamponade System (CTS-lOOO)

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 Clinical Innovations LLC .

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • 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
    This is to inform you of a voluntary global recall of clinical innovations’ ebb complete tamponade system (cts- 1000) involving lot numbers 1214—v-424; 1214-f-403 .The purpose of the recall is to address the potential for a balloon leak which may affect your ability to deliver therapy, when needed. clinical innovations’ records indicate you have received a product that is affected by this action. following a report that an ebb complete tamponade system (cts-looo) had leaked during use, clinical innovations conducted an investigation on the returned device and concluded that the leakage was caused by a failure mode of the bond at distal end of the uterine balloon a balloon leak can be identified by a failure to arrest bleeding, ultrasound revealing loss of balloon volume, or blood-tinged liquid being expelled from the drainage tube. a uterine balloon with a leak may not provide the anticipated tamponade effect, requiring further intervention. although unlikely, death could occur due to the failure mode associated with this recall. in the report received, the patient had stabilized prior to the leak being noticed by the clinical team. because there is a potential for additional interventions with a balloon leak (such as arterial embolization or surgery) required to control a postpartum hemorrhage, we are requesting that you return all unused ebb complete tamponade system (cts-looo) from the above—listed lot numbers. no other clinical innovations products are affected by this issue.