Events

Retiro De Equipo (Recall) de Plum A3 Triple Channel Infusion Pumps

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
    59956
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0010-2012
  • Fecha de inicio del evento
    2011-09-16
  • Fecha de publicación del evento
    2011-10-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104076
  • 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 continuous recycling and/or rebooting of plum a+ infusion pumps when the backlight intensity and/or display contrast settings for the led display has been adjusted from the original default setting. this condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/or rebooting.
  • Acción
    The firm, Hospira sent "URGENT DEVICE RECALL" letters dated September 16, 2011 to all affected customers. The letters identified the products, problem and action(s) to be taken. The customers were instructed to read the information provided carefully, complete the attached Reply Form and return it to Hospira via fax at 1-888-345-5358. The letter states that a software upgrade to address the issue is currently being developed. Customers were instructed to notify their consignees if they have further distributed the affected product. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002, option 4, for technical assistance. *** Follow-up letters dated June 26, 2012 were sent to the accounts listing the device modules with software versions v13.2, v13.3, v13.40 and v13.5 that will require the software upgrade. ***

Device

Plum A3 Triple Channel Infusion Pumps
  • Modelo / Serial
    a) list 12348 - serial numbers 0013740398 through 0013741025; b) list 12618 - serial numbers 0014040007 through 0018857420; c) list 20678 - serial numbers 0015543071 through 0019655471
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the US Virgin Islands, and countries of: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Ecuador, France, Greece, Hong Kong, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lebanon, Libya, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United kingdom, United Arab Emirates, Uruguay and Vietnam.
  • Descripción del producto
    Plum A+3 Triple Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 12348 - software version 10.3; b) list 12618 - software version 11.3; c) list 20678 - Hospira MedNet software || Product Usage: The Plum A+3 is a dual-line triple channel volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With their primary line, secondary line, and piggyback fluid delivery capability, the Plum A+3 is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories and the LifeShield¿ needleless protection systems makes the Plum A+3 a convenient and cost-effective infusion system.
  • 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