Events

Retiro De Equipo (Recall) de Sapphire 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 Hospira Pty Limited.

¿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-00624-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-07-16
  • 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-00624-1
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notas adicionales en la data
  • Causa
    Q core (the sapphire infusion pump original manufacturer) has received complaints from customers that when using the epidural mode with patient bolus, the amount of medication delivered may be greater than programmed. in the sapphire pump, as in all infusion systems, external factors may cause fluctuations in flow rate accuracy. investigation of these complaints determined that the deviation observed is exclusively related to the use of catheters with a gauge smaller than that used for the sapphire pump flow accuracy calibration. no patient injuries or deaths have been reported as a result of this issue.
  • Acción
    To address this issue, Q Core Medical is providing an addendum to the User Manual to assist customers in (i) identifying whether the catheter utilized may cause over-delivery, (ii) better understanding the effect of back pressure and catheter size on the accuracy of the delivered volume, (iii) translating the catheter’s back pressure to the degree of flow deviation that can be expected, and (iv) contacting Hospira Representative to determine if and to what extent specific catheter/pump combinations are susceptible to over-delivery. Future versions of the User Manual will incorporate the information contained in the addendum. This action has been closed-out on 30/08/2016.

Device

Sapphire Infusion Pump
  • Modelo / Serial
    Sapphire Infusion PumpHospira List Number: 163113601/163123601Q Core Number (on pump): 15031-000-0001 /15032-000-0001ARTG Number: 201499
  • Manufacturer
    Hospira Pty Limited

Manufacturer

Hospira Pty Limited
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA