Events

Retiro De Equipo (Recall) de Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)

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-2014-RN-01126-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-17
  • 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-2014-RN-01126-1
  • 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
    Qcore medical, the manufacturer of sapphire administration iv set ap424 has become aware of an increased incidence in specific batches of sets leaking in the sleeve areas (the adapter that connects between the tube and other components). the infusion set leaks may potentially result in under-dose or allergic reaction (in case the set is leaking and the drug comes into contact with the patient or healthcare professional) or increased risk of infection. the likelihood of harm will depend on the patient’s circumstances, such as the severity of their illness, the healthcare setting and the criticality of the infusion. qcore medical is not aware of any report of injury attributed to this defect.
  • Acción
    Hospira is requesting the users to check the AP24 set for leaks at the start of administration and to follow the instructions for use included with the Administration Sets and with the Sapphire Infusion Pump. New sets, without the defect should be available in mid November. This action has been closed-out on 01/03/2016.

Device

Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapph...
  • Modelo / Serial
    Sapphire Administration IV Set AP424 ( Patient Controlled Analgesia IV set for use with the Sapphire infusion pump)Catalogue Number: 611637201Product reference: 12003-000-0015List Number: 16372A9601Batch Numbers: 0167000814, 0167001414, 0167001514, 0167001914 and 0167002414ARTG Number: 200689
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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