Events

Retiro De Equipo (Recall) de Alaris SE Pump (formerly Signature Edition 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 Cardinal Health 303 Inc DBA Alaris Products.

¿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
    36064
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1484-06
  • Fecha de inicio del evento
    2006-08-10
  • Fecha de publicación del evento
    2006-09-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-07-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47889
  • 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
    This recall was initiated because of a potential for over infusion with all models of the alaris¿ se pumps (formerly the signature edition¿ infusion pumps) caused by key bounce.
  • Acción
    Corrective action for this recall will include notifications (five letters) being sent (Return Receipt) to all customers with affected product alerting them to this action. The letters are addressed to the Director of Biomedical Engineering, Director, Materials Management, Hospital Administration, Purchasing, and the fifth letter to the Director of Nursing. The August 15, 2006, recall letters and the warning labels will be sent return receipt requested. The verification of receipt of the notifications will be tracked and return receipt exceptions will be followed up. Follow up activities will be documented including customer contact.

Device

Alaris SE Pump (formerly Signature Edition Infusion Pump)
  • Modelo / Serial
    Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232. (ALL MODELS, ALL LOTS)  The serial numbers are not sequential.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and American Samoa, Guam, and Puerto Rico. Worldwide.
  • Descripción del producto
    Alaris¿ SE Pump (formerly Signature Edition¿ Infusion Pump); Model Numbers: 7000, 7100, 7101, 7130, 7131, 7132, 7200, 7201, 7230, 7231, and 7232
  • Manufacturer
    Cardinal Health 303 Inc DBA Alaris Products

Manufacturer

Cardinal Health 303 Inc DBA Alaris Products
  • Dirección del fabricante
    Cardinal Health 303 Inc DBA Alaris Products, 10221 Wateridge Cir, San Diego CA 92121-2733
  • Source
    USFDA