Events

Retiro De Equipo (Recall) de Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fresenius Medical Care Packs Australia.

¿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-01167-1
  • 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-01167-1
  • 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
    It has been reported that the needle cannula of the a.V fistula set for haemodialysis had separated from the needle hub and remained in the patient’s 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
    Fresenius is advising users to quarantine and destroy any affected units in stock. This action has been closed-out on 26/08/2016.

Device

Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis F...
  • Modelo / Serial
    Fresnius Medical Care (FME) Dialysis Fistula Pack 5 and Safety AVF Needle - Fixed Wing Dialysis Fistula Pack 5FME Material Number: AU850005FME Lot Number: 53818, 54477, 54881, 55299,57807,58263 and 58667Containing Terumo Material Number: AVFE1525CLFGTerumo Lot Numbers: 14071418,1410415,15012817,45051111Safety AVF Needle - Fixed WingFME Material Number: AU00086FME Lot Number: 14071418,14101415,1411011,1505111Terumo Material Number: AVFE1525CLFGARTG Numbers: 121471,130567
  • Manufacturer
    Fresenius Medical Care Packs Australia

Manufacturer

Fresenius Medical Care Packs Australia