Events

Retiro De Equipo (Recall) de CADDSolis Medication Safety Software

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 Smiths Medical ASD, Inc..

¿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
    69408
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0166-2015
  • Fecha de publicación del evento
    2014-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130449
  • 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, pca - Product Code MEA
  • Causa
    Smiths medical has identified an issue with a single batch (lot number 2752712) of cadd"-solis medication safety software administrator 3.1 cds. cadd"-solis medication safety software administrator 3.1 cds were sent with the cadd"-solis medication safety software point of care 3.1 software loaded on them.
  • Acción
    Consignees were hand delivered by Smiths Medical Sales representatives on 9/29/2014 a Smiths Medical "Urgent Field Safety Notice" dated 25-September-14. The letter described the problem and the product being recalled. The letter also provided the Advice on Action to be Taken by the User, Transmission of this Urgent Medical Device Recall Notice and requested consignees to complete and return the Confirmation Form by fax to 1-800-237-8033 or via email to recall.response@smiths-medical.com. For questions customers can contact Smiths Medical's Customer Service Department at 1-800-258-5361.

Device

CADDSolis Medication Safety Software
  • Modelo / Serial
    Lot Number 2752712
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution in the state of AK, CA, CO, CT, GA, MI, MN, NH, NC, SC, TX, VA, WI.
  • Descripción del producto
    CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. || Product Usage: || The CADD-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD-Solis VIP Ambulatory Infusion Pump, CADD-Solis Ambulatory Infusion Pump, or CADD-Prizm PCSII Ambulatory Infusion Pump (software revision H or higher). The CADD-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD-Solis Medication Safety Software.- Administrator to the CADD -Solis Ambulatory Infusion Pump and CADD-Prizm PCS I I Ambulatory Infusion Pump (software revision H or higher).
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • Dirección del fabricante
    Smiths Medical ASD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA