Events

Retiro De Equipo (Recall) de Device Recall ABACUS TPN Calculation Software, Baxa

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
    66989
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0539-2014
  • Fecha de inicio del evento
    2013-12-03
  • Fecha de publicación del evento
    2013-12-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124436
  • 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
    medical Computers and software - Product Code LNX
  • Causa
    Baxter healthcare corporation is issuing a voluntary correction for abacus total parenteral nutrition (tpn) calculation software versions 2.0 through 3.0 due to the possibility that a patient could receive another patient's tpn order as a result of data corruption.
  • Acción
    Baxter sent an Urgent Device Correction letter dated December 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check the patient order against the final bag label as part of the TPN acceptance procedure to ensure that the patient's TPN order is correct. Customers will be contacted by Baxter to arrange for installation of a software upgrade specific to their compounder's configuation. Customers were asked to acknowledge the receipt of this notification by completing the attached Customer Reply Form and return it to Baxter by fax to 1-224-270-5457 or scanning and emailing it to fca@baxter.com. If the product was distributed to other facilities customers were instructed to notify end-user customers in accordance with their customary procedures. Customers with questions were instructed to call 1-800-678-2292. For questions regarding this recall call 800-422-9837.

Device

Device Recall ABACUS TPN Calculation Software, Baxa
  • Modelo / Serial
    Product Code: 8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047,,8300-0045,,8300-0046,,8300-0047
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) || ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations and label printing. The primary use of Abacus is for TPN order calculations. Other uses of Abacus include: non-TPN volumes administered to patients on TPN therapy in order calculations; CVVH calculations; Cardioplegia (Buckburg) calculations; Epidural calculations; Dilutions from concentrated ingredient; Combinations of multiple ingredients; Fractional doses from larger volumes
  • 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