Events

Retiro De Equipo (Recall) de HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES

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
    125724
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-06-28
  • 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
    In very rare cases it is possible for a hl 20 twin pump module (tpm) to unintentionally increase its speed for a 1.5 - 2 second period of time before returning to its originally set speed. this malfunction can only occur when the tpm is used for cardioplegia and set up in a master/ slave configuration. during the malfunction a very transient incorrect mixing of the cardioplegia solution can occur before the pump speed returns to its original setting. this behavior can only occur when one of the tpm pumps is set as cardioplegia slave and the as cardioplegia master pump. when the tmp is used in any other confirguation this malfunction does not occur.

Device

HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES
  • Modelo / Serial
    Model Catalog: TPM 20-330 (Lot serial: > 10 numbers contact mfg)
  • Descripción del producto
    HL-20 PERFUSION SYSTEM - ROLLER PUMP MODULES
  • Manufacturer
    MAQUET-DYNAMED INC.

Manufacturer

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