Events

Retiro De Equipo (Recall) de PLUM A+ HYPERBARIC INFUSION SYSTEM

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
    56581
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-11-05
  • 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
    Certain plum a+ family infusion pumps in which the audio level rotary knob does not rotate in accordance with the information in the systems operating manual (som). the som indicate a clockwise rotation of the knob will decrease the alarm volume however in some plum a+ devices it has been found that the volume increases when the knob is turned clockwise.

Device

PLUM A+ HYPERBARIC INFUSION SYSTEM
  • Modelo / Serial
    Model Catalog: 11006 (Lot serial: All Serial numbers); Model Catalog: 11005 (Lot serial: All Serial numbers); Model Catalog: 20677 (Lot serial: All Serial numbers); Model Catalog: 12097 (Lot serial: All serial numbers); Model Catalog: 20792 (Lot serial: All serial numbers); Model Catalog: 20791 (Lot serial: All serial numbers); Model Catalog: 12391 (Lot serial: All serial numbers); Model Catalog: 20679 (Lot serial: All serial numbers)
  • Descripción del producto
    PLUM A+ Single Channel Infusers-V. Knob
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

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