Retiro De Equipo (Recall) de Device Recall Master Drug Library to be used with SIGMA Spectrum Infusion Pump

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
    70658
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1451-2015
  • Fecha de inicio del evento
    2015-03-02
  • Fecha de publicación del evento
    2015-04-16
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2018-05-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Loading/bolus default dose settings in the master drug library and the values shown on the pump during programming may differ. mdl drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). the pump will administer drugs as configured. the discrepancy may cause therapy delay or unintended rate of delivery.
  • Acción
    The firm, Baxter, sent an "Urgent Device Correction" letter dated 3/05/2015 with MDL Instructions were sent to all affected users via USPS First Class Mail on 3/05/2015. All four (4) limited launch locations with Master Drug Library (MDL) version 8.0 with SIGMA Spectrum Infusion System version 8.0 were notified via phone call on 3/02/2015. The letter describes the product, problem and actions to be taken. Baxter is requesting customers take the following actions: 1. Follow the steps described in Attachment 1 to confirm that this discrepancy is properly corrected. 2. Complete the enclosed customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. --- Baxter sent a follow-up Communication Letter (dated 3/17/2015) to the initial Urgent Device Correction Letter (dated 3/5/2015) to provide additional clarification and instructions to ensure continued mitigation of this discrepancy as users implement the Spectrum infusion System in their facility. The four launch sites received the follow-up letters via hand delivery; remaining customers received the follow-up letter via hand delivery and/or e-mail. If you have additional questions, please contact your Baxter sales representative, Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, during the hours of 7:00 am to 7:00 pm Eastern Time, or The Center for One Baxter at 800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

Device

  • Modelo / Serial
    Software version 8.0, Product Code 35723V080
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
  • Descripción del producto
    Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2 || The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Baxter Healthcare Corp, 1 Baxter Pkwy # Df6-3w, Deerfield IL 60015-4625
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA