Events

Retiro De Equipo (Recall) de CADD-PRIZM HIGH VOLUME ADMINISTRATION SET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    28217
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-03-21
  • 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.
  • Notas adicionales en la data
  • Causa
    Smiths medical has received a total of 22 complaints regarding occlusions/high pressure alarms experienced with cadd high volume administration sets 21-7081v-01 and 21-7381-01. please note 21-7081v-01 is not sold in canada. investigation of this issue has identified the root cause to be related to the incorrect filter size being used in one lot of finished goods. investigation to the root cause identified that the supplier had supplied a 0.2u filter instead of a 1.2 u filter. the 0.2u filter does not allow for the passage of lipids in tpn solution whereas the 1.2u filter does allow the passage of lipids. an indepth investigation concluded that the incorrect filter size was limited to 2 component part lot numbers which were put into production of 2 smiths medical finished goods lot numbers. only 1 lot number 21x221 applies to canadian product.

Device

CADD-PRIZM HIGH VOLUME ADMINISTRATION SET
  • Modelo / Serial
    Model Catalog: 21-7381-01 (Lot serial: 21X221)
  • Descripción del producto
    CADD High Volume Administration Sets
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC