Events

Retiro De Equipo (Recall) de Device Recall Plum 360 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., A Pfizer Company.

¿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
    76253
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1682-2017
  • Fecha de inicio del evento
    2016-12-30
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152590
  • 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
    Depleted battery alarm shows instead of replace battery. on battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. on ac power, the pump reboots (takes about 25 seconds). therapy can resume. ac power interruption of 3-7 seconds prompts an incorrect e323 alarm, ongoing therapy stop, and pump reboot. longer power loss results in battery power operation.
  • Acción
    On 12/30/2016, firm sent notification of the recall to Hospira direct consignees of record via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. Effectiveness of the communication will be confirmed by phone call with direct consignees who do not respond. The final disposition of the recalled product will be field correction (firm will contact consignees to upgrade the software in their Plum 360 infusion pumps).

Device

Device Recall Plum 360 Infusion Pump
  • Modelo / Serial
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Australia, New Zealand, Canada, Mexico, Chile, Philippines, Hong Kong, Greece, Ireland, Jordan, Kuwait, Oman, Poland, Saudi Arabia, Turkey, United Arab Emirates, Italy, France, United Kingdom, Spain
  • Descripción del producto
    Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions
  • Manufacturer
    Hospira Inc., A Pfizer Company

Manufacturer

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