Events

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

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
    76364
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1693-2017
  • Fecha de inicio del evento
    2017-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152976
  • 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
    Sigma spectrum infusion pumps with master drug library, software v8.00.02 contains an anomaly that may cause a sharp watchdog timeout error message. specifically, the software anomaly causes the error message only under conditions in which a message is being written to the spectrum infusion pumps event history log (ehl), and the length of that message exactly matches the size of the available memory at the end of a memory sector. for this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the ehl.
  • Acción
    URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.

Device

Device Recall Baxter SIGMA Spectrum Infusion Pump with Master Drug Library
  • Modelo / Serial
    14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Natiowide, Puerto Rico and Canada
  • Descripción del producto
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
  • 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