Events

Retiro De Equipo (Recall) de Hospira labelled MedNet Medication Management Suite – with 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-01336-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-10-23
  • 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-01336-1
  • 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
    Icu medical has identified issues with hospira labelled mednet medication management suite versions 6.1 and 6.21 when used with plum 360 drug library management that occurs during the import of a plum 360 drug library.The mednet meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. this includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback.A change to a piggyback rule set could result in a delay initiating a therapy or interruption of an active infusion. this issue could also lead to mixing of two infusion solutions. if two mixed solutions are incompatible particulates could form or, if during a transfusion, a blood clot could form in the administration set. in rare circumstances, these conditions could lead to serious adverse health consequences.
  • Acción
    ICU Medical is advising users that the issue arises during an import of a Plum 360 drug library. Users who have performed an import of a Plum 360 drug library or have the need to do so should refer to the information provided to customers to confirm if the drug library is affected during the import. A correction to the issues will be addressed in MedNet version 6.3.

Device

Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion System
  • Modelo / Serial
    Hospira labelled MedNet Medication Management Suite – with Plum 360 Infusion SystemVersion 6.1List Number: 16037-75-01Version 6.21List Number: 16037-75-02ARTG Number: 262489 (Hospira Pty Limited - Infusion pump medication dosage application software)
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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