Events

Retiro De Equipo (Recall) de cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A + 08089 Crea B membran

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Radiometer Pacific 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-00537-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-24
  • 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-00537-1
  • 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
    In november 2014, radiometer pacific notified customers (tga ref: rc-2014-rn-01201-i) that the ccrea results for qc decrease to below the lower acceptance limit within the lifetime of the crea membranes. the corrective action implemented at that time was to perform one quality control measurement every 24 hours using s7835 autocheck 6+, level 1 (944-094) to verify the ccrea performance. if the qc result was out of range, new crea a and crea b membranes had to be installed.Radiometer has now resolved the problem (starting with lot 557 and onwards) with narrowed specifications for the membrane material to reduce the diffusion rate through the membrane and has verified that the change brings the performance (drift and lifetime) back to the previous level.
  • Acción
    For membrane units below Lot 557: Continue to perform one quality control measurement every 24 hours using S7835 AutoCheck 6+, level 1 to verify the cCrea performance. If the QC result is out of range, new Crea A and Crea B membranes must be installed. Alternatively, if you wish to return any remaining unused units of cCrea membrane from Lots below 557 please contact your local Radiometer Account Manager on 1800 247 254. For membrane units of Lot 557 onwards: You may return to your standard practice for running QC for the cCrea membranes. This action has been closed-out on 17/08/2016.

Device

cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A ...
  • Modelo / Serial
    cCrea A+B Membranes used with ABL800 series blood gas analyser rangeItem # 942-073, 08088 Crea A + 08089 Crea B membranLot Numbers: 557 onwardsARTG Number: 229300
  • Manufacturer
    Radiometer Pacific Pty Ltd

Manufacturer

Radiometer Pacific Pty Ltd