Events

Retiro De Equipo (Recall) de ASENA GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BECTON DICKINSON CANADA INC..

¿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
    56590
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-05-04
  • 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
    While the pump is infusing a breakage of the plunger backplate spring may allow movement of the syringe plunger that may result in siphonage. neonatal and paediatric patients or those receiving critical drugs at low infusion rates would be considered to be the most at risk if small volumes of fluids reach the patient due to siphoning.

Device

ASENA GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE
  • Modelo / Serial
    Model Catalog: 80023GB01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80023FR01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80043UN01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80033UND1 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8002MED01-G (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80033UND1-G (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80023UN01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8005TIG01 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 8005PK201 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 80053UN01 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Descripción del producto
    ASENA GH;ALARIS TIVA SYRINGE PUMP (REBRANDING);ALARIS CC SYRINGE PUMP (REBRANDING);ALARIS GH SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE (REBRANDING);ALARIS CC SYRINGE PUMP WITH GUARDRAILS SAFETY SOFTWARE (REBRANDING);ALARIS GH SYRINGE PUMP (REBRANDING);
  • Manufacturer
    BECTON DICKINSON CANADA INC.

Manufacturer

BECTON DICKINSON CANADA INC.