Events

Retiro De Equipo (Recall) de Device Recall Medfusion 4000 Syringe Infusion Pumps

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
    66987
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0540-2014
  • Fecha de inicio del evento
    2013-11-22
  • Fecha de publicación del evento
    2013-12-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-03-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124427
  • 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
    Smiths medical is conducting a recall involving all medfusion¿ 4000 syringe infusion pumps. smiths medical has identified an issue with electrical shorting at the ac power receptacle. shorting can occur when saline solution or other conductive fluids (e.G., potassium chloride) enter the ac power receptacle. when this happens, sparking and/ or flames, accompanied by smoke, may appear at the ac po.
  • Acción
    Smiths Medical sent an "Urgent Medical Device Correction" letter dated November 22, 2013, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customers. All customers will be provided with instructions on inspection, cleaning, and prevention regarding this issue, for the continued safe and effective use of these pumps. Additionally, customers will be instructed to: 1. Return damaged pumps for servicing or damaged AC power cords for replacement to Smiths Medical. 2. Return the completed Confirmation Form to acknowledge receipt and understanding of the information provided in the Urgent Medical Device Correction letter, via fax or email, to Smiths Medical for processing. "The Instructions for preventing this issue", "Mitigations", Conclusions", " Action to be taken by the User", and "Transmission of this Urgent Medical Device Correction". The consignees were also asked to complete the "Urgent Medical Device confirmation Form" and fax it to 1-800-237-8033 or by sending an electronic copy via e-mail to medfusion4000nov2013@smiths-medical.com. For questions regarding this information, consignees should contact their local Sales Representative, Smiths Medical's Customer Service Department at 1-800-258-5361, or via e-mail at medfusion4000nov2013@smiths-medical.com. UPDATE: Consignees were sent a follow-up letter dated 13 January 2014 from the one dated November 22, 2013. The letter was addressed to Risk / Safety Managers, Biomedical Professionals, Clinicians who oversee the use of Medfusion Pumps, Distributors, and other users of these devices. The "Urgent Medical Device Recall" letter included Advise on Action to be Taken by the User. This included customers to have their Pumps undergo a free correction. The correction consists of the installation of a new AC power Receptacle seal. Smith Medical provided options for completing the correction process which included: 1) Consignees were a

Device

Device Recall Medfusion 4000 Syringe Infusion Pumps
  • Modelo / Serial
    All Medfusion¿ 4000 Syringe Pumps in the field are affected by this Field Safety Corrective Action.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide ) including the states of : AZ, NY, TN, MS, AR, WV, VA, VT, PA, DE, DC, OH, CO, NH, MI, CA, FL, CT, WA, MD, NM, RI, MA, TX, NC, IL, KY, WI and MI., and the countries of CANADA, SAUDI ARABIA and AUSTRALIA.
  • Descripción del producto
    Medfusion¿ 4000 Syringe Infusion Pumps || Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV solutions, drug solutions, blood or blood products, and enteral feedings in continuous, intermittent, and body weight delivery modes.
  • 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