Events

Alerta De Seguridad para analyzer for electrolytes and arterial gases

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 Manufacturing Ltd. || Siemens Healthcare Diagnostics Inc..

¿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
    I1501-16
  • Número del evento
    2009DM-0004077
  • Fecha
    2015-01-13
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=188
  • 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 the value resulting from the neonatal weakening factor (nbili) may be affected under specific conditions of equipment operation, leading to potential adverse events for patients.

Device

analyzer for electrolytes and arterial gases
  • Modelo / Serial
    Model RAPIDLAB 1245, RAPIDLAB 1265, RAPIDPOINT 405 and RAPIDPOINT 500, specific serials.
  • Descripción del producto
    The RAPIDPOINT® 400/405 instruments are analyzers for electrolyte and arterial gas tests at the patient's bedside by electrochemistry. Use samples of blood or capillary. It reports the values of PH, PCO2, PO2, HCO3-, CTCO2; CO-OXI, BE (ECF), O2SAT, O2CT, PO2 (AA), PO2 (A / A), FO2HB, FMETHB and FCOHB for gasessanguineal and electrolyte analysis NA +, K +, CA ++, CL-, LI +, Glucose, Lactate , HCT and HB. It is in a system designed for critical patients in surgery, uci and emergencies that report the values of the tests and communicates the declinical results of the patient. The reagents that are used with the RAPIDPOINT® equipment have respective health records.
  • Manufacturer
    Siemens Healthcare Diagnostics Manufacturing Ltd. || Siemens Healthcare Diagnostics Inc.

Manufacturer

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