Events

Retiro De Equipo (Recall) de SAPPHIRE MULTI-THERAPY INFUSION PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por HOSPIRA HEALTHCARE CORPORATION.

¿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
    131590
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2015-06-25
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
    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 medical has identified a software issue with q core saphirre multi therapy and epidural pumps with each of the software version r11v53 change set 12333 12334 and 12998 that may create a potential risk of over-delivery in specific situations.No patient injuries or deaths have been reported as a results of this issue. however q core has determined there is a significant patient safety risk due to the potential for over-delivery.

Device

SAPPHIRE MULTI-THERAPY INFUSION PUMP
  • Modelo / Serial
    Model Catalog: 15032-000-0011 (Lot serial: N/A); Model Catalog: 15031-000-0001 (Lot serial: N/A); Model Catalog: 15031-000-0013 (Lot serial: N/A); Model Catalog: 15032-000-0001 (Lot serial: N/A)
  • Descripción del producto
    Sapphire Multi-Therapy Infusion and Epidural Infusion Pumps
  • Manufacturer
    HOSPIRA HEALTHCARE CORPORATION

Manufacturer

HOSPIRA HEALTHCARE CORPORATION
  • Dirección del fabricante
    SAINT-LAURENT
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    HC