Events

Retiro De Equipo (Recall) de All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet Software

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Hospira Pty Limited.

¿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
    RC-2013-RN-00188-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-02-27
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00188-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
    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
    The distal pressure sensor calibration may have drifted and require re-calibration. the following error codes may be displayed during set up or infusion on the affected devices: e180/n180, e181/n181, e186/n186, e187/n187, e346. if distal pressure sensor drift occurs, the pump may not sense the build up of pressure and will not alarm when occlusion thresholds are exceeded.
  • Acción
    Hospira is providing end users with instructions to determine if they are affected by the issue. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Hospira is also in the process of evaluating the design of the distal pressure sensor to reduce the opportunity for pressure sensor drift. Additionally, a yearly test to determine if the distal pressure sensor’s calibration has drifted will be released in 2013.

Device

All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pum...
  • Modelo / Serial
    All Plum A+ Family of Infusers: Plum A+Single Channel Infusion Pump, Plum A+ and A+3 Infusion Pumps with MedNet SoftwarePlum A+Single Channel Infusion PumpCatalogue Number: 611239101Number on Pump: 12391 & 11971Plum A+ Infusion Pump with MedNet SoftwareCatalogue Number: 612079201Number on Pump: 20792Plum A+3 Infusion Pump with MedNet SoftwareCatalogue Number: 612067801Number on Pump: 20678
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA