Events

Retiro De Equipo (Recall) de MiniCap with Povidone-Iodine Solution

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter 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-2015-RN-00058-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-01-22
  • 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-00058-1
  • 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
    Baxter received complaints indicating that the iodine sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing.This may give rise to infusion of micro-organisms or by-products of microbes or other foreign materials into the peritoneal cavity, which may lead to bacterial or fungal peritonitis and/or infusion of inert foreign material into the peritoneal cavity which may lead to tissue injury or peritoneal membrane injury.These events are considered as catastrophic, however, the likelihood of this occuring has been calculated by the manufacturer as improbable (less than one in one million chance).
  • Acción
    Users are advised to inspect the product to ensure there is no damage to the MiniCap and that the sponge is fully within the cap. Do not use the product if the sponge is protruding or missing from the cap, and obtain a new MiniCap. For further information please see https://www.tga.gov.au/alert/minicaps-povidone-iodine-solution-used-peritoneal-dialysis.

Device

MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Pty Ltd