Events

Retiro De Equipo (Recall) de Baxter IPump Pain Management System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxter Healthcare Corp..

¿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
    33916
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0549-06
  • Fecha de inicio del evento
    2005-10-27
  • Fecha de publicación del evento
    2006-04-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-11-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42739
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, Infusion, Pca - Product Code MEA
  • Causa
    When infusing at flow rates below 0.5 ml/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.
  • Acción
    Baxter sent Urgent Device Correction letters dated 10/27/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for air to migrate through the silicone-pumping segment of the sets, which may result in air reaching the patient. Baxter recommended that the users of the I-Pump to enable the upstream occlusion sensor of the pump or to use sets containing air-elimination filters if the occlusion sensor is disabled or otherwise not activated. Baxter also recommended that for delivery routes other than epidural and subcutaneous at flow rates below 0.5 mL/hr, infusions should always be performed using a set containing an air eliminating filter (product codes 2L3513, 2L3520, 2L3523, 2L3525, 2L3526 and 2L3527). For users of the APII Pump Baxter recommended that all infusions on the APII, for delivery routes other than epidural and subcutaneous, should be performed using a set containing and air-eliminating filter. Baxter sets not containing an air-eliminating filter (product codes 2L3510 and 2L3511) should not be used with the APII device, and should not be used with the I-Pump when infusing at rates less than 0.5 mL/hr. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump, with the warning to use only Baxter sets with air-eliminating filters with the AP II pump to avoid undetected air-in-line at low flow rates. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the number of additional copies of the addendum needed.

Device

Baxter IPump Pain Management System
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, including Puerto Rico, and internationally to Canada, Chile and China
  • Descripción del producto
    Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA