Events

Retiro De Equipo (Recall) de Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

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 Corporation.

¿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
    79177
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0971-2018
  • Fecha de inicio del evento
    2017-10-06
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161516
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
  • Acción
    An Urgent Medical Device Correction, dated October 6, 2017, was sent to customers. The letter described the problem, identified the affected device, discussed the hazard involved, and action to be taken. Customers were asked to locate the affected products at their facility. Customers should continue to follow the instructions in document 41394 Rev. A, PREVENTIVE MAINTENANCE, for their entire fleet of pumps. Baxter will inspect affected pumps. To arrange for return of devices that have failed the flow rate accuracy test, contact Baxter Healthcare Medina. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Urgent Medical Device Correction. If there are additional questions, customers can contact their Baxter Sales Rep or Baxter Healthcare Medina at 800-356-3454.

Device

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
  • Descripción del producto
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. || Intended to be used for the controlled administration of fluids.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Dirección del fabricante
    Baxter Healthcare Corporation, 711 Park Ave, Medina NY 14103-1036
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA