Events

Retiro De Equipo (Recall) de MEDICATION CASSETTE RESERVOIR

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
    44005
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-02-03
  • 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 small number of complaints of leakage in some cadd medication cassette reservoirs 50ml. a small amount of leaking has been found to occur at the welding of the tube to the internal reservoir bag on some cassettes. if noticed during cassette filling it could result in a delay of therapy while an alternative cassette is obtained. if noticed during fluid delivery with the patient it could result in an interruption in therapy while the cassette is replaced. smiths medical has received no reports of serious injury or death related to this issue.

Device

MEDICATION CASSETTE RESERVOIR
  • Modelo / Serial
    Model Catalog: 21-7001-24 (Lot serial: 14X-297); Model Catalog: 21-7301-24 (Lot serial: 14X-297); Model Catalog: 21-7001-24 (Lot serial: 14X-323); Model Catalog: 21-7301-24 (Lot serial: 14X-323); Model Catalog: 21-7001-24 (Lot serial: 14X-324); Model Catalog: 21-7301-24 (Lot serial: 14X-324)
  • Descripción del producto
    CADD MEDICATION CASSETTE RESERVOIR50ML
  • 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