Events

Retiro De Equipo (Recall) de Device Recall Deltec 3000 Large Volume 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 Smiths Medical MD, 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
    47482
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1604-2008
  • Fecha de inicio del evento
    2008-02-27
  • Fecha de publicación del evento
    2008-09-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=69558
  • 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
    Large Volume Infusion Pump - Product Code FRN
  • Causa
    The deltec, graseby, and 3m, large volume infusion pump - models 3000 and 3100, may deliver an unintended bolus if the pump door is opened and then immediately closed. this problem is due to a timing delay when the pumping mechanism resets itself.
  • Acción
    A Smiths Medical "Urgent Medical Device Correction" letter dated 2/5/08 was sent to consignees on 2/27/08. The letter was addressed to Risk/Safety Managers, Clinicians, Nursing Staff and other users of the above products. The letter also included Details on affected devices, Description of the problem , Advice on action to be taken by the user, Warning and requested the return the confirmation form. Contact Smiths Medical at 1-800-426-2448 for assistance. Please note: The 3M was the original brand for the large volume infusion pump models 3000 and 3100 marketed in the USA from 1994 through 1997. The Graseby large volume infusion pump models 3000 and 3100 were marketed from 1997 through 1999. Since 1999, the current marketed brand is the Deltec models 3000 and 3100. Smith Medical MD, Inc., included the 3M and Graseby brand large volume infusion pumps in the product field safety notice in the event these brands of infusion pumps are still in use.

Device

Device Recall Deltec 3000 Large Volume Infusion Pump,
  • Modelo / Serial
    All serial numbered devices affected.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AR, AZ, CA, CO, CT, DC, FL. GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, ,MO, MS, MT, NC, ND, NE,NH, NJ, NM, NV, NY, OH, OK OR,PA, RI,SC, TN, TX, UT,VA, VT, WA, WI, WV, and WY
  • Descripción del producto
    Deltec¿ 3000 Large Volume Infusion Pump, CE 0473, RX Only, Smiths Medical MD, Inc. 1265 Grey Fox Road, St. Paul, MN 55112, USA, Made in UK. || Reorder numbers 21-5301-01 & 21-5306-01 || The product is used for general drug delivery infusion therapies. The product is only intended to be used by trained clinicians.
  • Manufacturer
    Smiths Medical MD, Inc.

Manufacturer

Smiths Medical MD, Inc.
  • Dirección del fabricante
    Smiths Medical MD, Inc., 1265 Grey Fox Rd, Saint Paul MN 55112-6929
  • Source
    USFDA