Events

Retiro De Equipo (Recall) de SynchroMed II Implantable Infusion Pump

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-2014-RN-00037-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-01-23
  • 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-2014-RN-00037-1
  • 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 synchromed ii pump software update will automatically correct the following two issues:1) erroneous replace by date: the updated software corrects the issue previously communicated in medtronic’s march 2012 (tga ref: rc-2012-rn-00260-3) i.E., in some circumstances after a pump’s elective replacement indicator (eri) has occurred, the “schedule to replace the pump by” date may be incorrectly displayed as a series of question marks (??/??/????), or as a date greater than 90 days from the eri date, potentially leading to the pump reaching end of service (eos) prior to replacement.2) premature reservoir alarm: the updated software corrects the potential for premature low and empty reservoir alarms. these premature alarms are due to an incorrect calculation within the 8840 programmer software. the majority of these alarms occur within the clinic immediately following an interrogation.
  • Acción
    1) Medtronic does not recommend prophylactic explant of devices because these issues are addressed automatically and non-invasively with the software card update. Until the software application card is updated in the programmer: - Clinicians may continue to use the present software card. - Continue the normal follow up schedule, and monitor the estimated number of months until Elective Replacement Indicator (ERI). - Follow labelled recommendations for pump replacement within 90 days of ERI declaration. 2) In the case of a low or empty reservoir alarm: - Review the calculated residual volume displayed on the 8840 programmer to assess if the alarm is premature. - After the software update, any previous version of the model 8870 software application card should no longer be used and can be returned to Medtronic. For more details, please see http://www.tga.gov.au/safety/alerts-device-medtronic-synchromed-II-140204.htm .

Device

SynchroMed II Implantable Infusion Pump

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA