Events

Retiro De Equipo (Recall) de Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pump with Hospital 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-2012-RN-01281-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-01-04
  • 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-2012-RN-01281-1
  • 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 door roller assembly on the plum a+/a+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over delivery during the removal of the iv administration set's cassette from the pump.
  • Acción
    Hospira will fit a redesigned roller door to reduce the potential for the roller door assembly to break. Until the correction can be made Hospira is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Unlatch the cassette door from the opener handle assembly by pushing on the door release tab and open the door fully. -Visually inspect the door roller pin for any evidence of the damage or door roller misalignment. -Ensure that the door roller spins smoothly with a finger touch.

Device

Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pum...
  • Modelo / Serial
    Plum A+ Infusion Pump; Plum A+ Infusion Pump with Hospital MedNet Software; Plum A+3 Infusion Pump with Hospital MedNet SoftwarePlum A+ Infusion PumpList number: 12391, 11971Plum A+ Infusion Pump with Hospira MedNet SoftwareList number: 20792Plum A+3 Infusion Pump with Hospira MedNet SoftwareList number: 20678ARTG Number: 138109
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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