Events

Alerta De Seguridad para Analyzer for Electrolytes and Gases RAPIDPOINT

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 Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing 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
    I1706-206
  • Número del evento
    2009DM-0004077
  • Fecha
    2017-06-02
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=84
  • 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 establishes that the demographic information of the patient (surname, name, sex, date of birth) can be misassigned, when the patient's id field is left blank in multiple samples and a recovery of the patient's information is initiated, leading to present adverse events on patients due to confusion in the identification of results.

Device

Analyzer for Electrolytes and Gases RAPIDPOINT
  • Modelo / Serial
  • Descripción del producto
    RAPIDPOINT 400/405 instruments are analyzers for electrolyte and arterial gas tests at the patient's bedside by electrochemistry. It uses arterial or capillary blood samples. It provides the values of Ph, Pco2, Po2, Hco3-, CtCo2; Co-Oxi, Be (Ecf), O2sat, O2ct, Po2 (AA), Po2 (A / A), Fo2hb, Fmethb and Fcohb for blood gases and electrolyte analysis Na +, K +, Ca ++, Cl-, Li +, Glucose, Lactate , Hct And Hb. It is a system designed for critical patients in surgery, uci and emergencies that reports the values of the tests and communicates the results of the patient's clinics. The reagents used with the RAPIDPOINT equipment have their respective health records.
  • Manufacturer
    Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd

Manufacturer

Siemens Healthcare Diagnostics Inc. || Siemens Healthcare Diagnostics Manufacturing Ltd
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA