Events

Retiro De Equipo (Recall) de Device Recall Symbiq One Channel Infuser

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
    63993
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0353-2017
  • Fecha de inicio del evento
    2013-02-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115183
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    Hospira has received reports of malfunction s205 backup battery failure alarms in symbiq v3.13 pumps. this issue to an incorrect installation of components on some of the power supply controller (psc) boards distributed prior to september 2012. on pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. because of the battery depletion, or lack of charge, a visual and audible warning alarm, s205, is displayed. an s205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
  • Acción
    Hospira sent an Urgent Field Device Correction letter dated Feburay 5, 2013, to all affected customers. Hospira has implemented a correction to the manufacturing process to address this issue. Symbiq v3.13 pumps that have been shipped from Hospira since September 2012 and pumps that were upgraded to v3.13 in the Field after September 2012 are not impacted by this issue. If you are unsure of when you were shipped Symbiq v3.13 pumps or when your devices were upgraded, contact Hospira. Please complete the attached reply form and return it via fax number or e-mail address on the form, even if you do not currently have the impacted infuser. lease contact Stericycle at 1-866-201-9072 (M-F, Bam - 5pm EST) to obtain additional copies of the reply form. If you have further distributed these devices, please notify your accounts who may have received these infusers from you and ask them to contact Stericycle at 1-866-201-9072 (M-F, 8am- 5pm EST) to receive a reply form.

Device

Device Recall Symbiq One Channel Infuser
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide) and Canada
  • Descripción del producto
    Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. || The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood, and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Dirección del fabricante
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    USFDA