Events

Retiro De Equipo (Recall) de Device Recall Volumetric 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 Walkmed Infusion LLC.

¿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
    56750
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0307-2011
  • Fecha de inicio del evento
    2010-06-17
  • Fecha de publicación del evento
    2010-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94445
  • 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
    Infusion Pump - Product Code FRN
  • Causa
    Pump door may be in a near shut position, but unlatched, and the "door open" alarm may not sound.
  • Acción
    All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.

Device

Device Recall Volumetric Infusion Pump
  • Modelo / Serial
    Serial numbers: 1 thru 500, TR1041 through TR2559.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AL, CA, FL, and PA.
  • Descripción del producto
    WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. || Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
  • Manufacturer
    Walkmed Infusion LLC

Manufacturer

Walkmed Infusion LLC
  • Dirección del fabricante
    Walkmed Infusion LLC, 96 Inverness Dr E Ste N, Centennial CO 80112-5311
  • Empresa matriz del fabricante (2017)
    Walkmed Infusion LLC
  • Source
    USFDA