Events

Retiro De Equipo (Recall) de Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below

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-2015-RN-01153-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-02
  • 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-2015-RN-01153-1
  • 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
    There may be a delay in delivery of pain medication when using epidural mode with patient bolus on sapphire multi-therapy & sapphire epidural pumps that have software v11.00 or lower installed. on these pumps, this delay can only occur if the user attempts to start the infusion without first opening the clamp.Under specific conditions, if a treatment that is programmed in epidural mode is started by the user without the user opening the clamp, the pump may not detect an occlusion. this resultant potential delay in therapy may happen, if, and only if, all of the following conditions occur concurrently:a. the clamp is left closed at the “start” of the treatment; andb. the treatment is set at epidural mode; andc. the programmed treatment is set to “bolus only”, i.E., the basal rate=0;this specific combination of conditions may only occur with pumps that have software v11.00 or lower. there is a potential risk of delay in the pain therapy.
  • Acción
    Hospira is advising users to upgrade software on the affected devices. Additionally, Hospira is reminding users to ensure the clamp is open when starting an infusion. This action has been closed-out on 06/09/2016.

Device

Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and below
  • Modelo / Serial
    Sapphire Multi-Therapy and Sapphire Epidural Pumps with software versions 11.00 and belowHospira List Numbers:163113601 and 163123601Q Core Number (on pump): 15031-000-0001 and 15032-000-0001ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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