Events

Retiro De Equipo (Recall) de Blood Pressure Monitoring Kits with Transpac IV Transducers

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ICU Medical Australia 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-2016-RN-01335-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-10-19
  • 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-2016-RN-01335-1
  • 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 identified that there is a potential for leaks with certain monitoring kits that contain the transpac iv transducers. a small number of these devices may have the potential to leak or introduce small amounts of air into the line. in a worst case, there is potential patient harm due to air embolism or contamination. icu medical, inc. has not received any reports of adverse events associated with this issue.
  • Acción
    ICU Medical is advising customers to arrange for their stock to be recovered and replacement stock, or a credit note to be issued. This action has been closed-out on 24/05/2017.

Device

Blood Pressure Monitoring Kits with Transpac IV Transducers
  • Modelo / Serial
    Blood Pressure Monitoring Kits with Transpac IV TransducersKit - Royal Women Hospital QLD, Special Care Nursery (Item: 011-0J069-01, Lot: 3253136)Kit - Neonatal/Childrens Australia (Item: 011-46103-16, Lot: 3263780)Safeset Transpac IV (Item: 011-46103-25, Lot: 3207778)Transpac IV (Item: 011-46104-49, Lot: 3242280)Single Line Monitoring Kit w/Transpac IV (Item: 011-46104-52, Lot: 3253165)Single Line Transpac IV Monitoring Kit (Item: 011-46107-16, Lot: 3235355)ARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA