Events

Retiro De Equipo (Recall) de GAMBRO AK-200 ULTRA

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
    106558
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-19
  • 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 become aware that some users have not followed the start-up procedures when performing online priming with the ak200 ultra s. patients are at risk of receiving priming solution if the start-up procedures for on-line priming described in the operator's manual are not followed when preparing the ak 200 ultra s for a patient treatment. a patient may receive priming solution if the operator/user: fails to properly attach the venous line in the venous clamp during the priming procedure and fails to verify the illumination of the machine blood path indication after patient connection and fails to confirm start of treatment.

Device

GAMBRO AK-200 ULTRA
  • Modelo / Serial
    Model Catalog: AK-200 ULTRA S (Lot serial: 12593); Model Catalog: AK-200 ULTRA S (Lot serial: 18143); Model Catalog: AK-200 ULTRA S (Lot serial: 18142); Model Catalog: AK-200 ULTRA S (Lot serial: 15683); Model Catalog: AK-200 ULTRA S (Lot serial: 12591); Model Catalog: AK-200 ULTRA S (Lot serial: 13299); Model Catalog: AK-200 ULTRA S (Lot serial: 19696); Model Catalog: AK-200 ULTRA S (Lot serial: 19695); Model Catalog: AK-200 ULTRA S (Lot serial: 12592); Model Catalog: AK-200 ULTRA S (Lot serial: 15681)
  • Descripción del producto
    AK 200 ULTRA S
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION