Events

Retiro De Equipo (Recall) de Device Recall Logix Order Entry (OE) Software

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
    58420
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2291-2011
  • Fecha de inicio del evento
    2011-03-29
  • Fecha de publicación del evento
    2011-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-01-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99299
  • 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 - set, i.v. fluid transfer - Product Code LHI
  • Causa
    The logix oe automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. the software stores backup files in numeric order rather than chronological date order.
  • Acción
    Baxter Healthcare Corp. sent an URGENT DEVICE CORRECTION letter dated March 29, 2011, via first class mail to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. It was discovered there is an issue with the LOGIX OE automated backup not retaining the three most recent backup files and instead will only retain the last three backups of the previous year. The accounts were requested to turn off the automated backup function on the LOGIX OE Software, and perform manual backups following the instructions included in the Urgent Device Correction letter, and retain a copy of the letter at each computer on which LOGIX OE Server is installed. The customer were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.

Device

Device Recall Logix Order Entry (OE) Software
  • Modelo / Serial
    catalog 2M8410, all software versions
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA including Puerto Rico, and the country Canada.
  • Descripción del producto
    LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; || The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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