Events

Retiro De Equipo (Recall) de Device Recall Plum A Infusion Pump with Hospira 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
    64542
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2682-2017
  • Fecha de inicio del evento
    2013-02-01
  • Fecha de publicación del evento
    2017-07-07
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-31
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154421
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    A possible interruption of therapy when an e321 error code occurs while using the infuser, which is caused by battery issues.
  • Acción
    Hospira has contracted with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by UPS tracking. Customers will be requested to return a reply form to Stericycle indicating they have received the letter, and notified their customers. The customers will also be asked to supply the number of Plum A+ infusers at their facility.

Device

Device Recall Plum A Infusion Pump with Hospira MedNet Software
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and U.S. Virgin Islands; and countries of: Costa Rica and Dominican Republic.
  • Descripción del producto
    The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. || The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.
  • 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