Events

Retiro De Equipo (Recall) de All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy 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-2013-RN-00245-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-11
  • 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-00245-1
  • 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
    Leakage from the aa battery causes a barrier to the power contacts resulting in no power being delivered, and in some instances the leakage results in contamination or corrosion of the power circuitry. excessive voltage ingress (voltage from the outside ac power adapter) to voltage regulators can cause them to fail. failure of these regulators may result in the device shutting off without issuing a warning or an audible or visual alarm. if the device shuts off it will result in a delay/interruption in therapy.
  • Acción
    As directed by the Gemstar Technical Service Manual (TSM), the internal AA batteries and battery compartment should be inspected for signs of leakage, corrosion or other damage prior to each use. In addition, each time the batteries are replaced the battery compartment should be inspected for damage. If a device exhibits damage caused by leaking batteries, immediately remove it from clinical service and return it to Hospira for repair. Healthcare professionals are advised to weigh the risk/benefit to patients associated with the use of the device when administering critical therapies. Customers should consider the use of an alternative pump, particularly in patients in which delay/interruption in therapy or under/over infusion could result in significant injury or death.

Device

All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infus...
  • Modelo / Serial
    All GemStar Family of Infusers: GemStar Infusion System - Single Therapy, GemStar 7 Therapy Infusion SystemGemStar Infusion System - Single TherapyCatalogue number: 611308801Number on pump: 13088/13150GemStar 7 Therapy Infusion SystemCatalogue number: 611308701Number on pump: 13087/13000
  • Manufacturer
    Hospira Pty Limited

Manufacturer

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