Events

Retiro De Equipo (Recall) de Hospira Acclaim Encore 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 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
    67591
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1483-2014
  • Fecha de inicio del evento
    2013-10-31
  • Fecha de publicación del evento
    2014-05-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-08-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125798
  • 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
    Broken door assemblies on the hospira/abbott acclaim encore infusion pumps. if the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. if the door cannot be closed, the pump cannot be used which can result in a delay in therapy.
  • Acción
    URGENT MEDICAL DEVICE CORRECTION letters, dated October 31, 2013, were sent to all direct accounts. The letters identified the affected product, as well as the reason for recall, risk to health, and instructions for device users. Users are to inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy by following the provided instructions. The letter also included instructions for recipients to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions; and complete the attached reply form and return it to the fax number or e-mail address on the form. Customers are to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain additional reply forms if needed. If the devices were further distributed, those customers should be notified and asked to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. The letter reminds customers that Hospira is retiring the Acclaim Encore infusion pump and will no longer support them as of December 31, 2014.

Device

Hospira Acclaim Encore Infusion Pump
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
  • Descripción del producto
    Hospira Acclaim Encore Infusion Pump || Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.
  • 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