Events

Retiro De Equipo (Recall) de Device Recall Baxter FloGard 6300 Dual Channel Volumetric Infusion Pump

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
    36872
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0635-2007
  • Fecha de inicio del evento
    2006-11-27
  • Fecha de publicación del evento
    2007-03-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-01-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49484
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    There is the potential for non-detection of, and no alarm for, upstream occlusion for flo-gard volumetric infusion pumps, if an occlusion occurs above a flexible chamber such as a drip chamber, buretrol or blood filter.
  • Acción
    Baxter sent the 11/27/06 Urgent Device Correction letter to all Flo-Gard Volumetric Infusion Pump customers, to the attention of the Vice President of Nursing and the Biomedical Engineer, via first class mail to alert them to the potential for non-detection of, and no alarm for, upstream occlusion under specific conditions for Flo-Gard Volumetric Infusion Pumps if the occlusion occurs above a flexible chamber (such as a drip chamber, Buretrol or blood filter), and to provide the addendum to the operator manual to address these specific conditions. The letters included the mitigations and risks associated with each of the conditions that could potentially cause this situation. This information was included in the letter, as well as the Operator''s Manual Addendum, which Baxter requested to attach a copy to all Flo-Gard Operator''s Manuals in their facility. Baxter instructed the customers to share this information with all staff members, services and facilities that use Flo-Gard pumps. Any questions were directed to Baxter''s Global Technical Services at 1-800-843-7867, prompt 2. Although Baxter previously notified customers on 3/5/99 that they would no longer support or service the Flo-Gard 6200 and 6300 devices as of 12/1/99, these product codes were included in this letter due to a similar potential for this issue. Should the customer still have these 6200 or 6300 devices in their possession, Baxter recommended that they be taken out of service due to obsolescence of the appropriate components. The accounts were requested complete the enclosed reply form acknowledging receipt of the letter and dissemination of the information to their staff.

Device

Device Recall Baxter FloGard 6300 Dual Channel Volumetric Infusion Pump
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA, Puerto Rico, Argentina, Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, El Salvador, Guatemala, Hong Kong, Honduras, India, Indonesia, Ireland, Italy, Korea, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Poland, Russia, Singapore, Slovakia, Slovenia, South Africa, Sweden, Taiwan, Thailand, Turkey, United Kingdom and Venezuela.
  • Descripción del producto
    Baxter Flo-Gard 6300 Dual Channel Volumetric Infusion Pump, catalog #2M8048, 2M8048R (refurbished); 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