Events

Retiro De Equipo (Recall) de Device Recall Hospira Symbiq Infusion System with MedNet 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 Hospira 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
    50541
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0944-2009
  • Fecha de inicio del evento
    2008-12-03
  • Fecha de publicación del evento
    2009-02-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-03
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75724
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
    Infusion Pump - Product Code FRN
  • Causa
    Hypersensitivity to normal motor friction/drag may cause malfunction errors and alarms that are designed to stop pump operations.
  • Acción
    Recall initiated 12/03/2008. Consignees were notified of the issue via an Urgent: Device Field Correction letter, dated 12/3/2008, and were requested to respond appropriately to any alarm or warnings displayed by the device. The firm is making arrangements to screen each Symbiq pump in customer facilities and implement the appropriate enhancements.

Device

Device Recall Hospira Symbiq Infusion System with MedNet Software.
  • Modelo / Serial
    All products manufactured between 12/19/06 to 12/02/08 with list numbers 16026-04-01/03/04, 51/52, 79/80 and 81/82, or 16027-04-01/03/04, 51/52, 53/54, 79/80, and 81/82.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including USA and countries of Canada and Australia.
  • Descripción del producto
    Symbiq One-Channel list number 16026-04 and Two-Channel list number 16027-04 Infusion System, a general purpose infuser, Distributed and Manufactured by Hospira Inc, Morgan Hill, CA. || Is a general purpose infuser designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration. || Intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as but not limited to Home Care, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Dirección del fabricante
    Hospira Inc, 755 Jarvis Dr, Morgan Hill CA 95037-2810
  • Source
    USFDA