Events

Retiro De Equipo (Recall) de Multi Lumen and Pressure Injectable Central Venous Catheters

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Mayo Healthcare Pty Ltd.

¿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-00613-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-18
  • 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-00613-1
  • 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 is a low level of occurrence (<0.02%) of the lumen exit and lumen size on the extension line being misprinted on central venous catheters (cvc). as an example, the distal lumen may be printed with the word 'medial 18 ga' instead of 'distal 16ga'. misprinted labelling can cause user dissatisfaction with flow rates (ml/hr) in the case the lumen would be expected to perform as labelled for high volume gravity infused (the mismarked 16ga lumen) since in reality this is an 18ga lumen and gravity flow is approximately half (1/2) the expected flow rate in ml/hr for a 16ga lumen. this could result in a worst case scenario clinical intervention to use a pressure bag or pump to achieve adequate flow rates. the colour coding of all hubs is correct and corresponds to the arrow system.
  • Acción
    Mayo Healthcare Pty Ltd is advising their customers to be aware of the incorrect labelling.

Device

Multi Lumen and Pressure Injectable Central Venous Catheters
  • Modelo / Serial
    Multi Lumen and Pressure Injectable Central Venous CathetersAffected Lot Numbers: 71F14A0329, RF1082062, 71F13H0637, ZF3063390, 71F14C0868, ZF1124891, ZF3051182, 71F13K0810, 71F13J1589, 71F14C0173, ZF2052625, 71F13H0972, 71F13K1389, 71F13K1796, 71F13K0429, ZF2111681, 71F13H1291, 71F13L0166, 71F14A0120, 71F13K1808, 71F14A1404, 71F13K0325, 71F13L1212, 71F14B0386, ZF3052590, RF0127942, 71F13K1625, ZF2123457, 71F14B0029, RF1069981, RF0087867, ZF3040526, 71F14B0377 ARTG Number: 142543
  • Manufacturer
    Mayo Healthcare Pty Ltd

Manufacturer

Mayo Healthcare Pty Ltd