Events

Retiro De Equipo (Recall) de AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier

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-2016-RN-01415-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-11-01
  • 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-01415-1
  • 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
    Two software issues have been identified, as follows.1. it has been identified that the machine could become stuck in a fluid by-pass state if the operator confirms the air detector alarm during priming. in a fluid bypass state, the fluid path bypasses the dialyzer and no ultrafiltration (uf) or diffusion occurs, leading to an absence of therapy. thus, the patient may not receive the prescribed therapy when the machine gets stuck in a bypass state.2. it has been identified that the ultrafiltration supervision (ufs) may be put in an (non-functional) idle state, if the functional check of the blood module is delayed and is completed after the functional check of the fluid module. when the ufs is in a non-functional state, the machine may not be able to detect deviations in ultrafiltration during treatment. this could lead to hypovolemia or hypervolemia.
  • Acción
    Baxter is advising users that a software update will be released early 2016 as a permanent fix. Baxter will contact users to arrange for the upgrade once the new software version is available. In the interim, the following instructions should be followed. 1. Make sure that the blood pump door is closed during the Function Check i.e. before “Green Fluid Path” is reached. 2. Wait to put the blood lines and the dialyser on the machine until the machine has reached Green Fluid Path.

Device

AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier
  • Modelo / Serial
    AK 98 Self-Care Haemodialysis machine with software versions 1.1.0 and earlier Product Code: 115250Serial Numbers:11295, 10357, 10359, 10360 &10362ARTG Number: 112135
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd