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
    15297
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-09-28
  • 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 corporation is issuing a device correction for the sigma spectrum infusion pump with master drug library (spectrum infusion pump) in order to replace speakers installed in pumps that have an increased potential to fail prematurely. the speaker is intended to generate audible tones during each keystroke and during alarm conditions. however some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. spectrum infusion pumps with non-functional speakers will continue to display visual alarm indications and will otherwise continue to operate as intended. before using an affected spectrum infusion pump users should confirm the generation of an audible tone as instructed in the device operator manual.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Modelo / Serial
    Model Catalog: 35700BAX (Lot serial: > 10 contact manufacturer); Model Catalog: 35700BAX2 (Lot serial: > 10 contact manufacturer)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (V6 & V8)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION