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
    I1508-361
  • Número del evento
    2014EBC-0011258
  • Fecha
    2015-08-04
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=174
  • 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 notifies that when using the bolus epidural infusion mode, the amount of medication delivered may be greater than the programmed one, when catheters with larger internal diameter are used than to adjust the flow precision of the pump (gauge <20), leading to present potentially adverse events on the patient.

Device

Infusion Pump SAPPHIRE
  • Modelo / Serial
    SAPPHIRE serial 163111301, 16311303, 163113601, 163116501, 163121301, 163121303, 163123601 and || 163126501
  • 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