Events

Retiro De Equipo (Recall) de CDI BLOOD PARAMETER MONITORING SYSTEM 500

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por RYAN MEDICAL DISTRIBUTORS INC..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    38714
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-03-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Specific cdi blood parameter monitoring system 500 devices are being voluntarily recalled because the bpm sensor head assembly's thermistor which provides the blood temperature value that results in accurate display values on the monitor does not meet specification. this may cause inaccurate temperature measurement and inaccurate analyte display values on the cdi system 500 monitor. terumo cardiovascular systems (ryan medical distributors inc.) received complaints of inaccurate temperature measurements for specific devices distributed since november 5 2015. these include both new production devices and recently serviced devices.

Device

CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Modelo / Serial
    Model Catalog: 500AHCT (Lot serial: 3623); Model Catalog: 500AV (Lot serial: 3623); Model Catalog: 500AVHCT (Lot serial: 3623); Model Catalog: 500AHCT (Lot serial: 3030); Model Catalog: 500AVHCT (Lot serial: 3587); Model Catalog: 500AVHCT (Lot serial: 3030); Model Catalog: 500AHCT (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3587); Model Catalog: 500AV (Lot serial: 3030)
  • Descripción del producto
    CDI BLOOD PARAMETER MONITORING SYSTEM 500
  • Manufacturer
    RYAN MEDICAL DISTRIBUTORS INC.

Manufacturer

RYAN MEDICAL DISTRIBUTORS INC.