Events

Alerta De Seguridad para extracorporeal circulation system for heating

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Rand S.R.L..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    I1705-156
  • Número del evento
    2013EBC-0010835
  • Fecha
    2017-05-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=91
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer informs about a possible quality problem affecting the referenced devices, which have a quick connector female and a white protective cap inside the connector, it has been detected that in some occasions the cover is a little loose and could fall accidentally, leading to that there are possible adverse events on the patient or delays in the surgical procedure.

Device

extracorporeal circulation system for heating
  • Modelo / Serial
  • Descripción del producto
    The PERFORMER HT system, together with its accessories and consumables, make up an electromechanical system used to treat local hyperthermia by circulating hot fluids in the peritoneal or pleural cavity. It is particularly indicated in the following therapies: 1. Intraperitoneal or intrapleural perfusion in order to help localized hyperthermia through heated defluid circulation, which may contain chemotherapeutic drugs, in the peritoneal or pleural cavity. 2. Isolated perfusion of the organ consisting of isolating an anatomical area followed by an intra-arterial perfusion of chemotherapeutic drugs under hyperoxia / hypoxia conditions.
  • Manufacturer
    Rand S.R.L.

Manufacturer

Rand S.R.L.
  • Empresa matriz del fabricante (2017)
    Rand Spa
  • Source
    NIDFSINVIMA