Events

Retiro De Equipo (Recall) de Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Maquet 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-2017-RN-00093-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-20
  • 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-00093-1
  • 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
    Maquet has identified an issue with the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidentally dropped, the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the operator/user instructions, battery venting has the potential to create smoke, a foul odour, and sparks. there has been no reported patient harm or adverse events attributable to this issue. there have been 3 reported occurrences of the battery venting when dropped to date.
  • Acción
    A Maquet Representative will schedule an on-site visit to affix a “Do Not Drop” label on the battery and provide additional instructions which will indicate to take extra care to avoid dropping the battery. Additionally, Maquet is in the process of providing a re-usable transport and storage case which will allow for the transport and storage of spare batteries. Future shipments of CARDIOSAVE Li-Ion batteries from Maquet will be shipped in the re-usable transport and storage container. Users are advised not to take spare batteries for transport applications, until they are provided with the re-usable transport and storage case.

Device

Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP)
  • Modelo / Serial
    Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP) Part Number: 0146-00-0097All Li-Ion Batteries distributed from December 12 2011 to November 9 2016ARTG Number: 118266
  • Manufacturer
    Maquet Australia Pty Ltd

Manufacturer

Maquet Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    DHTGA