Events

Retiro De Equipo (Recall) de Device Recall Medfusion Syringe Pump, 4000 Series

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
    77761
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0313-2018
  • Fecha de inicio del evento
    2017-08-22
  • 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=157839
  • 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
    Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "invalid syringe size" alarm.
  • Acción
    The firm,Smiths Medical, sent an, "Urgent Medical Device Recall" Amendment Notice (amending the original August 2017) concerning invalid syringe size alarms on certain Medfusion¿ Syringe Pump Model Series 3500 and 4000. The letter described the product, problem, actions to be to taken, and updated changes, as follows: 1. Locate the affected Medfusion¿ Syringe Pump(s) by referring to the list of affected devices on the attached Urgent Medical Device Recall Notice Response Form. This form provides the specific serial number(s) your organization purchased. Each pump has a unique serial number which can be found on the label located on the bottom of the pump. If you have ten (10) or more affected pumps in your possession, please select one of the following repair options: a. Repair at your Facility: Contact Smiths Medical to schedule a technician to visit your facility and complete the necessary repairs onsite. b. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. c. NEW OPTION - Biomedical Department self-repair at your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. If you have nine (9) or fewer affected pumps in your possession: a. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Customer Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. b. NEW OPTION - Biomedical Department Self-Repair at Your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. To initi

Device

Device Recall Medfusion Syringe Pump, 4000 Series
  • Modelo / Serial
    Model No. 4000; Reference No. 4000-0101-51
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Descripción del producto
    Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. || In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Dirección del fabricante
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    USFDA