Events

Alerta De Seguridad para Infusion Pump SAPPHIRE

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 Q Core Medical Ltd.

¿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
    I1606-242
  • Número del evento
    2014EBC-0011258
  • Fecha
    2016-06-09
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=137
  • 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 states that it has identified a problem with the current air detection method in the tube with the unique combination of opacity and infrared absorption, where in a specific range for iron sucrose concentrations a signal recognized by the algorithm could be emitted. as detection of air in the tube, resulting in a false alarm "air in piping", which can lead to conferments for users and potentially serious adverse events on the patient.

Device

Infusion Pump SAPPHIRE
  • Modelo / Serial
    Sapphire Epidural / 163122901 and 163982901
  • Descripción del producto
    Delivery controlled through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline sera, total parenteral nutrition (TPN), lipids, IV medicine, epidural medication, blood and blood products. The SAPPIHRE pump includes the following infusion modes for all intended uses: continuous, intermittent, TPN, PCA, multi-step and epidural. Labomba is indicated to be used both by health professionals in a clinical environment and by home users in an ambulatory environment. The SAPPHIRE pump is designed to follow the patient through the various areas of care and is suitable for use in different configurations
  • Manufacturer
    Q Core Medical Ltd

Manufacturer

Q Core Medical Ltd