Events

Retiro De Equipo (Recall) de PLUM 360 INFUSION SYSTEM WITH MEDNET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HOSPIRA HEALTHCARE CORPORATION.

¿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
    62866
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-10-08
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
    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
  • Causa
    When the user selects "yes" at the "new patient?" screen and the program was not changed prior to powering off the infuser the distal occlusion pressure setting is assigned a values of 15 psi (775 mmhg) instead of the default value. in addition the user interface will incorrectly display the default distal occlusion pressure value. the default value is set at 6 psi from the manufacturer. the user would not be immediatly aware of the unintended occlusion pressure setting unless the user views the current distal pressure value on the infuser display and it is greater that the distal pressure alarm limit. this may result in delay of therapy related to delay in identifying the occlusion cause.

Device

PLUM 360 INFUSION SYSTEM WITH MEDNET
  • Modelo / Serial
    Model Catalog: 30010-13 (Lot serial: >10 S/N contact manufacturer)
  • Descripción del producto
    Plum 360 Infusion System with MedNet
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Dirección del fabricante
    SAINT-LAURENT
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    HC