Events

Retiro De Equipo (Recall) de Sorin Perfusion System - S5/C5 Heart Lung Machine

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Cellplex 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-2013-RN-01283-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2013-12-05
  • 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-2013-RN-01283-1
  • 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
    The manufacturer, sorin group deutschland gmbh has received reports of some malfunctioning em1 model shaft encoders in the pumps. the encoder housing can be exposed to excessive traction resulting in the speed encoder becoming non-responsive and displaying an error message "shaft angle encoder fault". this fault results in the encoder code wheel coming in contact with the silicone detector cover and drawing out the silicon material from the detector housing. if the pump module has to be replaced and the perfusionist is not able to maintain the blood flow within 3 minutes, the situation may lead to oxygen under supply. it may be necessary to hand crank the pump or operate the cp5 manually in case of a pump control failure.
  • Acción
    Cellplex is advising users that the affected pumps should not be used as an arterial pump. Prior to the use of the affected pumps, users are advised to rotate the speed encoders to ensure that complete smooth transition occurs. If there is excessive traction, DO NOT use the pump. Cellplex is advising that all affected pumps used as arterial pumps will be replaced by loan pumps until the correction is performed. All affected units will be corrected by Cellplex.

Device

Sorin Perfusion System - S5/C5 Heart Lung Machine
  • Modelo / Serial
    Sorin Perfusion System - S5/C5 Heart Lung MachineS5 Roller PumpProduct Code: 10-80-00Multiple Serial NumbersS5 Double Roller PumpProduct Code: 10-85-00Multiple Serial NumbersS5 Control Panel for Mast Roller Pump 150Product Code: 28-95-80Serial#: 50E60933, 50E60951 and 50E60946Pump Control Panel (CP5)Product Code: 60-02-60Serial #: 60E10351 and 60E10353ARTG Numbers: 108387, 94208
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Cellplex Pty Ltd

Manufacturer

Cellplex Pty Ltd