Events

Retiro De Equipo (Recall) de PLUM A+3 INFUSION PUMPS

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
    26749
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-02-21
  • 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
    Hospira received reports related to distal pressure sensor calibration drift on plum a+ infusers. if the distal pressure sensor calibration drifted it will need to be recalibrated. the following error codes may be displayed during setup or infusion signifying possible calibration drift: e180/n e181/n181 e186/n186 e187/n187 or e346. additionally if the pressure sensor calibration has drifted user may expericence nuisance (false) digital occlusion alarms or distal occlusions that may not be detected. these errors invoke visual and audible warnings to the users.

Device

PLUM A+3 INFUSION PUMPS
  • Modelo / Serial
    Model Catalog: 20678 (Lot serial: All serial numbers); Model Catalog: 11005 (Lot serial: All serial numbers); Model Catalog: 20679 (Lot serial: All serial numbers); Model Catalog: 12391 (Lot serial: All serial numbers); Model Catalog: 20792 (Lot serial: All serial numbers); Model Catalog: 12618 (Lot serial: All serial numbers)
  • Descripción del producto
    ALL PLUM A+/A+3 FAMILY OF INFUSERS
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

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