Events

Retiro De Equipo (Recall) de SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

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

¿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
    34958
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-09-08
  • 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
    Baxter has identified a limited number (2) of sigma spectrum infusion pumps with master drug library product code 35700bax that may not have been correctly serviced according to established procedures by one service technician during the time period of may 5 2014 through june 3 2014. while these pumps passed testing requirements following service baxter cannot be assured that each device is free of workmanship defects that may impact pump performance and safety.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

Manufacturer

BAXTER CORPORATION