Events

Retiro De Equipo (Recall) de ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC

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
    63785
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2016-11-30
  • 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 safety alert communication to inform customers of the potential for disconnection of the artiset bloodline (luer of arterial and/or venous patient connector) from the patient access site (needle/catheter) during treatment. baxter has identified a potential for increased likelihood of disconnection during post-market surveillance activities. the arterial and venous patient connectors are designed in compliance with the applicable international standards iso594 and iso8638 allowing safe connection to vascular accesses. the post-market surveillance reports of disconnection of the artiset bloodline from the patient access site were caused by the healthcare provider improperly connecting the two devices. to address this issue baxter is providing additional instructions on how to properly connect the devices.

Device

ARTISET BLOOD TUBING SET FOR HAEMODIALYSIS HD SN HC
  • Modelo / Serial
    Model Catalog: 114533 (Lot serial: LOT 1634 AND ONWARDS)
  • Descripción del producto
    Artiset Blood Tubing Set For Haemodialysis HD SN HC
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION