Events

Retiro De Equipo (Recall) de PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers

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-01288-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-10
  • 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-01288-1
  • 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 lifecare 5000 series and plum xl 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 is requesting hospitals to take the following steps to inspect the door assemble prior to loading the cassette: -Open the cassette door by pulling on the lever - Unlatch the cassette door by pushing on the door release tab and pulling the door down. -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. If any door rollers or pins appear losse, broken or missing, Hospira is advising to remove the device from use. Hospira is in the process of retiring the Plum LifeCare 5000 and Plum XL in 2015.

Device

PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers
  • Modelo / Serial
    PLUM LifeCare 5000 Series and PLUM XL Familiy of Infusers Plum LifeCare 5000List Number: 02507Plum XLList Number: 11555Plum XLMList Number: 11846Plum XLDList Number: 11859ARTG 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