Events

Retiro De Equipo (Recall) de Device Recall Plum A SIngle 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
    57724
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1644-2011
  • Fecha de inicio del evento
    2011-02-14
  • Fecha de publicación del evento
    2011-03-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97093
  • 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 customer reports of the plum a+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues.
  • Acción
    The firm, Hospira, sent "URGENT DEVICE RECALL" letters dated February 14, 2011 to their customers on the same date. The letter described the product, problem and action to be taken by the customers. The Customer/Clinicians were instructed to weigh the risk associated with continued use of the device versus removal from service. If they elect to continue the devices, they were provided with instructions to perform alarm tests prior to each clinical use (during their pump cleaning process). If the alarm is not audible, they were instructed to discontinue use of the pump and contact Hospira Global Product Safety and Complaints at 1-800-441-4100. The customers were requested to contact Hospira Advanced Knowledge Center at 1-800-241-4002 for technical assistance. The accounts were also requested to complete the attached Reply Form and return it to Hospira via fax at 1-888-216-7330.

Device

Device Recall Plum A SIngle Channel Infusion Pumps
  • Modelo / Serial
    a) list 11971- serial numbers 0013120009 through 0099072443;  b) list 11973 - serial numbers 0012570148 through 0012579183;  c) list 12391 - serial numbers 0013840001 through 0013890171;  d) list 20679 - serial numbers 0015441019 through 0015459165;  e) list 20792 - serial numbers 0016061001 through 0018787700
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: United States including the U.S. Virgin Islands and Puerto Rico, and countries including: Argentina, Australia, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, 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, Uruguay, United Arab Emirates and Vietnam.
  • Descripción del producto
    Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: || a) list 11971 || b) list 11973 - software version 10.3 || c) list 12391 - software version 11.3 || d) list 20679 - Hospira MedNet Software || e) list 20792 - Driver || The Plum A+ dual-line 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+ 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+ 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