Events

Retiro De Equipo (Recall) de Device Recall Baxter's Patient Care System

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
    32449
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0033-06
  • Fecha de inicio del evento
    2005-06-16
  • Fecha de publicación del evento
    2005-10-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40109
  • 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
    Software, Transmission And Storage, Patient Data - Product Code NSX
  • Causa
    If a pharmacy end user alters the administration unit of measure (auom) of an ordered drug, the auom will display incorrectly on the medication administration record for the patient, possibly leading to medication errors.
  • Acción
    Urgent Device Correction recall letters dated 6/16/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the Administration Unit of Measure (AUOM), and informed the accounts that changing the AUOM of an ordered drug presents a patient safety issue resulting in a potential for a medication error. The accounts were requested to eliminate or minimize any further AUOM changes until a software upgrade is available. If an AUOM change is required the pharmacy end user must contact the Baxter Patient Care Helpdesk at 1-877-835-2727 prior to any changes being made. A Technical Bulletin was provided with the letter to guide the pharmacy end user through the process of an AUOM change with the aide of a Client Support Specialist.

Device

Device Recall Baxter's Patient Care System
  • Modelo / Serial
    Software version 4.1-77, 4.0-66 and 3.4-18.24
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Missouri, Massachusetts, Vermont, California and Canada.
  • Descripción del producto
    Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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