Events

Retiro De Equipo (Recall) de Plum 360 Infusion System

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-2017-RN-01335-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-25
  • 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-2017-RN-01335-1
  • 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
    Two issues have been identified with the plum 360 infusion system involving the distal occlusion auto restart (doar) feature and preventative maintenance (pm) due notification.Issue 1 - if the doar feature is enabled and a distal occlusion occurs, the pump will be in a "paused" state. if a malfunction alarm occurs while the pump is in the paused state waiting for the distal pressure to decrease, the pump cannot be turned off nor delivery restarted until the battery is discharged or disconnected. once the battery is recharged or reconnected, the pump can be returned to clinical service.Issue 2 - when the pm screen is accessed from the main biomed settings menu on pumps that have accumulated a total delivery time greater than 1500 hours, the user will not be able to interact with the pump and the pump must be power cycled. once this is done, the pump can be returned to clinical service. there have been no reports of a serious injury or death related to these issues.
  • Acción
    For Issue 1: Hospira is providing work around instructions for users to follow as a interim measure. For Issue 2: Hospira is advising users to not enable the optional Preventative Maintenance Due Notification feature. A software update will be implemented as a permanent correction.

Device

Plum 360 Infusion System
  • Modelo / Serial
    Plum 360 Infusion SystemSoftware version: 15.10.00.010List Number: 30010ARTG Number: 234421
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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