Events

Retiro De Equipo (Recall) de MediRedi Fistula Packs Melbourne Health Unit Fistula Pack, Melbourne Health Unit Fistula Pack, A.V. Fistula Set for Haemodialysis

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por House With No Steps Hunter Valley Region.

¿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-01214-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-10
  • 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-01214-1
  • 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.
  • Notas adicionales en la data
  • Causa
    There are four reports worldwide, where the needle cannula of the av fistula set for haemodialysis had separated from the needle hub and remained in the patients’ vein when attempting to remove the needle following the completion of the dialysis treatment. although the possibility of occurrence for such an event is extremely low, there is potential that blood leakage could occur should the needle cannula separate from the hub and remain in the patient’s vein.There have been no reports of patient injury as a result of this issue.
  • Acción
    Baxter is advising users to stop using the A.V Fistula set for Haemodialysis from the affected population. Customers are advised to quarantine and destroy all product in the affected stock. This action has been closed-out on 29/08/2016.

Device

MediRedi Fistula Packs Melbourne Health Unit Fistula Pack, Melbourne Health Unit Fistula Pack, A....
  • Modelo / Serial
    MediRedi Fistula PacksMelbourne Health Unit Fistula PackProduct Code: FG00605 (SAP 114827) Batch Numbers: 1503091, 1504158, 1505197, 1506221, 1705275, 1508296, 1508328, 1509369Melbourne Health Unit Fistula PackProduct Code: FG00620 (SAP 114539) Batch Numbers: 1503099, 1505195, 1506231, 1507263, 1508293, 1509348, 1510389A.V. Fistula Set for HaemodialysisProduct Code: AVFE 1525CLFGBatch Numbers: 140714I8, 141014I5, 141110I1, 150128I7, 150511I1ARTG Number: 167750
  • Manufacturer
    House With No Steps Hunter Valley Region

Manufacturer

House With No Steps Hunter Valley Region
  • Source
    DHTGA