Events

Retiro De Equipo (Recall) de Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Terumo Cardiovascular Systems Corporation.

¿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
    76386
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1235-2017
  • Fecha de inicio del evento
    2015-05-27
  • Fecha de publicación del evento
    2017-02-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153034
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Causa
    Terumo cardiovascular systems corporation has received complaints indicating that the sarns centrifugal pump (disposable pump heads) have exhibited leaks. the leaks were detected during priming of the bypass circuit and during cpb procedures. in each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. terumo cardiovascular system's investigation into the incident has identified the cause of the leaks to be cracks in both the top housing and magnet back housing of the pump. when the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
  • Acción
    Customer Notification Letter/Response Form is being sent to all affected consignees.

Device

Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump
  • Modelo / Serial
    TAOS, TC03
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
  • Descripción del producto
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Dirección del fabricante
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA