Events

Retiro De Equipo (Recall) de Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-2017-RN-00049-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-04-27
  • 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-2017-RN-00049-1
  • 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
    Based on overseas reports from a customer, bd/carefusion identified regarding a potential risk of syringe siphonage with pumps that have a broken “plunger back plate spring” in the plunger back plate assembly. a breakage of the plunger backplate spring may allow movement of the syringe plunger within the plunger holder mechanism which could result in siphonage. in some circumstances, this may result in a clinically significant over infusion especially in neonatal and paediatric patients, or those receiving critical drugs, at low infusion rates.
  • Acción
    CareFusion is advising users to check the age of the pump by referring to the label on the rear case and to replace the plunger backplate spring (refer to Information Notice IN0221) on syringe pumps older than three years. Clinical areas such as neonatal, paediatric and critical care, where critical drugs are delivered at lower infusion rates are to be prioritised. In the event that users see a "Check Syringe" alarm without an identifiable cause, they are requested to remove the pump from clinical use for examination by a qualified service personnel in accordance with the Alaris Syringe Pump Technical Service Manual.

Device

Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral)
  • Modelo / Serial
    Alaris Syringe Pumps (GH, CC, TIVA, PK and Enteral) - All VariantsProduct Codes: with prefix 8001, 8002, 8003, 8004 and 8005 (all variants)All Serial NumbersARTG Number: 177501
  • Manufacturer
    CareFusion Australia 316 Pty Ltd

Manufacturer

CareFusion Australia 316 Pty Ltd