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-00180-1
  • 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-00180-1
  • 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 plum a+ fluid shield diaphragm may be out of specification and cause n250 "door open while pumping" or n100 "unrecognisable cassette" alarms. hospira inc have advised that these alarms invoke audible and visual warnings to the user which may occur during setup, infusion or performance verification test and will cause the device set up to be interrupted or the infusion to stop. if these alarms occur whilst the clinician is setting up the pump or an infusion is in progress, a delay or interruption in therapy may result.
  • Acción
    If the unrecognisable cassette alarm occurs during the loading process prior to infusion starting, remove the cassette and attempt to reload the cassette again. If the alarm happens multiple times it is recommended to get a new tubing set or remove the device from service. To correct this issue, Hospira has implemented a screening process to identify fluid shields that are out of specification. Plum devices shipping from Hospira since September 2012 have diaphragms that have been screened for the undersized dimension. Hospira will be contacting customers to arrange for screening and replacement of impacted fluid shields.

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