Events

Retiro De Equipo (Recall) de Baxter Interlink System MicroInfusion Manifold

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
    56892
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0502-2011
  • Fecha de inicio del evento
    2010-10-21
  • Fecha de publicación del evento
    2010-12-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94872
  • 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
    Intravascular Administration Set - Product Code FPA
  • Causa
    If the manifolds are connected in series, there may be a risk of the manifolds loosening or disconnecting at the luer connection between them.
  • Acción
    Baxter sent an "Urgent Device Correction" letter dated October 20, 2010, via first class mail to the direct accounts, to the attention of the Director of Nursing and the Director of Materials Management, informing them that there may be a risk of the manifolds loosening or disconnecting at the luer connection between them. The loosening or disconnection can result in an interruption of therapy, potentially resulting in patient injury and death. The accounts were requested to place the notification where the inventory of affected product is dispensed, so that users are made aware of the procedures to follow: "If these devices are connected in series, and the luer connector is tightened, do not twist the manifolds. This may lead to loosening or disconnection, which may cause a leak. Additionally, Baxter recommends checking all connections before starting and during infusion therapy." The accounts were requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they can comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.

Device

Baxter Interlink System MicroInfusion Manifold
  • Modelo / Serial
    product code 2N3410 and A2N3410 , all lots
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States and Japan.
  • Descripción del producto
    Baxter Interlink System, Micro-Infusion Manifold; and Interlink Manifold. An Rx sterile device with 3 injection sites, volume per injection site 0.1 mL, priming volume 0.8 mL, length 8.7 cm. Product code 2N3410 and A2N3410 - Japan || Baxter Healthcare corporation, Deerfield, IL 60015 USA; || Intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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