Events

Retiro De Equipo (Recall) de HEMODIALYSIS SYSTEM SERIES 1550 W/DOUBLE PUMP SINGLE NEEDLE

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
    72943
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2005-01-31
  • 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
    Manufacturer has received reports of air bubbles in the tubing sets past the air detectorwithout an alarm alerting the operator of potential air in the tubing. potentially could cause air embolisms.

Device

HEMODIALYSIS SYSTEM SERIES 1550 W/DOUBLE PUMP SINGLE NEEDLE
  • Modelo / Serial
    Model Catalog: 5M5551 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 5M5538 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-D (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-DH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPP-H (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3P (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000GIA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PHA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PDP (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3PH (Lot serial: ALL SERIAL NUMBERS); Model Catalog: SYS1000-L3DPA (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENASPX-O (Lot serial: ALL SERIAL NUMBERS); Model Catalog: ARENA SPX (Lot serial: ALL SERIAL
  • Descripción del producto
    HEMODIALYSIS SYSTEM SERIES 1550
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION