Events

Alerta De Seguridad para equipment and accessories for cardiac monitoring

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 Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V..

¿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
    R1611-517
  • Número del evento
    2009DM-0004837
  • Fecha
    2016-11-16
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=114
  • 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 reports that it has received reports about delays in some of the referenced devices, which could potentially introduce small amounts of air in the line, leading to the occurrence of adverse events in patients.

Device

equipment and accessories for cardiac monitoring
  • Modelo / Serial
    Concerning monitoring kits with Transpac IV transducers, references and specific batches.
  • Descripción del producto
    Invasive medical devices to determine the cardiovascular pressure of the patient and some hemodynamics: PVC (central venous pressure) PAPA (pulmonary arterial pressure), PCP (pulmonary capillary pressure), PAS (systemic arterial pressure), PVI (left ventricular pressure), PAI (pressure left atrial) and PA (blood pressure and supply of intravenous solutions required in these processes).
  • Manufacturer
    Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V.

Manufacturer

Hospira Costa Rica Ltd || ICU Medical Inc Salt Lake City || ICU Medical De México S. A. C. V.
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    NIDFSINVIMA