Events

Retiro De Equipo (Recall) de PERFUSION SET WITH SOFTLINE COATING

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MAQUET CARDIOPULMONARY GMBH.

¿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
    66568
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-07-28
  • 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
    Maquet cardiopulmonary gmbh (mcp) internal investigations have revealed that the specification of the performance factor (pf) at flow rates of 1 liter per minute is not always maintained as defined in instruction for use (ifu). deviations up to minus 20% were identified during in-house testing.

Device

PERFUSION SET WITH SOFTLINE COATING
  • Modelo / Serial
    Model Catalog: BO-HQV 46904 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-H 55815 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: CHX 30 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-H 48730 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-H 95260 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-H 55161 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-HQV 52700-1 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-HQV 46901 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-HQV 46904 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-HQV 46900 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-H 48761 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BEQ-H 48721 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-HQV 66606 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-HQV 66605 (Lot serial: MFG 2015.07.31 - 2017.07.31); Model Catalog: BO-HQV 66604 (Lot serial
  • Descripción del producto
    PERFUSION SET WITH SOFTLINE COATING;PLEGIOX HEAT EXCHANGER;PERFUSION TUBING PACK WITH BIOLINE COATING;CARDIOPLEGIA SET WITH SOFTLINE COATING;PERFUSION SET WITH BIOLINE COATING;CUSTOM PACK WITH SOFTLINE;CARDIOPLEGIA SET WITH BIOLINE COATING;HEART LUNG PERF
  • Manufacturer
    MAQUET CARDIOPULMONARY GMBH

Manufacturer

MAQUET CARDIOPULMONARY GMBH
  • Dirección del fabricante
    RASTATT
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    HC