Events

Retiro De Equipo (Recall) de Device Recall Abacus 3.1

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 Corporation Englewood.

¿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
    68256
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1847-2014
  • Fecha de inicio del evento
    2014-05-28
  • Fecha de publicación del evento
    2014-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127226
  • 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
    System/device, pharmacy compounding - Product Code NEP
  • Causa
    Baxter corporation is initiating a field correction following an upgrade to abacus software v3.1, when clinimix 4.25110 is used in an order, the nutritional summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
  • Acción
    Baxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to fca@baxter.com. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.

Device

Device Recall Abacus 3.1
  • Modelo / Serial
    Product Code: 8300-0167, 8300-0168, 8300-0169
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution and the state of VA.
  • Descripción del producto
    Abacus 3.1, Pharmacy Calculator || Product Usage: || Provide pharmacy calculations for automated compounding.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Dirección del fabricante
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA