Events

Retiro De Equipo (Recall) de SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET-DYNAMED 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
    22884
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2017-07-19
  • 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
    Manufacturer has determined that condensation in the drain line tubing may lead to a false blood detection alarm activating when no blood is present. also liquid spills such as saline can create bridges of resistance between the circuit components causing the circuit not to function as intended. this can impact initiation or continuation of therapy.

Device

SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP
  • Modelo / Serial
    Model Catalog: 0998-00-0446-XX (Lot serial: S806023-D2); Model Catalog: 0998-00-0446-XX (Lot serial: S803570-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803551-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803492-B0); Model Catalog: 0998-00-0446-XX (Lot serial: S803634-C0); Model Catalog: 0998-00-0446-XX (Lot serial: S804566-L0); Model Catalog: 0998-00-0446-XX (Lot serial: S81995-A9); Model Catalog: 0998-00-0446-XX (Lot serial: S803567-B0); Model Catalog: 0998-00-3013-XX (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 0998-00-0446-XX (Lot serial: S803785-E0); Model Catalog: 0998-00-0446-XX (Lot serial: S803639-C0); Model Catalog: 0998-00-0479-XX (Lot serial: S806816-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S806811-A3); Model Catalog: 0998-00-0479-XX (Lot serial: S805908-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S805907-B2); Model Catalog: 0998-00-0479-XX (Lot serial: S81212-H8); Model Catalog: 0998-00-0479-XX (Lot serial: S804785-B1); Model Catalog: 0998-00-3023-53 (Lot serial:
  • Descripción del producto
    SYSTEM 98 (IABP) INTRA-AORTIC BALLOON PUMP;CS100 INTRA AORTIC BALLOON PUMP;SYSTEM 98XT INTRA AORTIC BALLOON PUMP;CS300 INTRA AORTIC BALLOON PUMP SYSTEM - MAIN UNIT
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

MAQUET-DYNAMED INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC