Events

Rappel de Terumo Advanced Perfusion System 1

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Terumo Cardiovascular Systems Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    62313
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2443-2012
  • Date de mise en oeuvre de l'événement
    2012-09-10
  • Date de publication de l'événement
    2012-09-24
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110196
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Console, heart-lung machine, cardiopulmonary bypass - Product Code DTQ
  • Cause
    Terumo cardiovascular systems (cvs) received two reports of the false back flow alarms for the terumo¿ advanced perfusion system 1 when there was no tubing in the flow sensor. terumo cvs' investigation found that the voltage level on a circuit board was improperly set in a population of flow modules for terumo system 1, the sensor operates correctly if the tubing is installed and it is highly unli.
  • Action
    Terumo CVS issued an URGENT MEDICAL DEVICE Recall letter dated September 10, 2012 to alert all affected customers. The letter identified the affected product, problem and actions to be taken. The letter states that a Terumo CVS representative will contact all affected US account.to schedule an appointment to replace the affected product. The affected product will be return to Terumo for destruction. Non-US Terumo Affiliates will be instructed to remove the devices from the field and provide a record of destruction. For questions call the Terumo CVS Customer Service at 1-800-521-2818

Device

Terumo Advanced Perfusion System 1
  • Modèle / numéro de série
    Catalog number: 802018 and serial numbers: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, and 00823-00847.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide and US Nationwide Distribution
  • Description du dispositif
    Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD || Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA