Events

Notificaciones De Seguridad De Campo acerca de Decapsmart, model Estorflow

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 MEDICA S.p.A..

¿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
    2017-02-20
  • 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
    The aforementioned risk is as follows: if you press the plunger knob to the right during the normal procedure for replacing the heparin syringe, moving the plunger to the left by 1 ml when the heparin syringe has already been inserted into the tubing system and placed in the appropriate bay , the patient may be injected up to 9 ml anticoagulation solutions (heparin) due to automatic piston movement that cannot be controlled by the operator.   an overdose of heparin may cause the following problem in patients: bleeding or hemorrhage, including fatal outcome, depending on the concentration of solution used.   uncontrolled heparin injection can only occur if the procedure shown in the video is not followed consistently when using the device while replacing the syringe.

Device

Decapsmart, model Estorflow
  • Modelo / Serial
    72000915, 72000114, 72002412, 72003813, 72002812, 72002912, 72000313, 72000815, 72000512
  • Manufacturer
    MEDICA S.p.A.

Manufacturer

MEDICA S.p.A.
  • Empresa matriz del fabricante (2017)
    Medica Spa
  • Source
    AMPMDRS