Events

Rappel de Device Recall 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
    61231
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1964-2012
  • Date de mise en oeuvre de l'événement
    2012-06-22
  • Date de publication de l'événement
    2012-07-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107622
  • 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 (terumo cvs) received two complaints related to the gas system for the terumo advanced perfusion system 1. both were reported instances of users experiencing difficulty adjusting the system 1 gas system local flow control knob.
  • Action
    Terumo CVS sent an "URGENT MEDICAL DEVICE RECALL-SAFETY ADVISORY" letter dated June 22, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Contact Terumo CVS Customer Service at 1-800-521-2818 for questions regarding this recall.

Device

Device Recall Terumo Advanced Perfusion System 1
  • Modèle / numéro de série
    catalog number: 801764 and Serial numbers: 0006-0066, 0100-0311, 0313-0322,1001-1027,1100-1434,1436, 1440, and 1441.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ARGENTINA, BELGIUM, CANADA, CHILE, COLOMBIA, Costa Rica, Dominican Republic, Egypt, Germany, Guatemala, Honduras, Hong Kong, India, Indonesia, Israel, Japan, Jordan, Kuwait, Malaysia, Mexico, Pakistan, Philippines, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), and Vietnam.
  • Description du dispositif
    Terumo Advanced Perfusion System 1 || System 1 Base, 220/240 V. || The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit. It also provides monitoring of the carbon dioxide if 95-5 (%oxygen/%carbon dioxide) is used as the blending gas.
  • 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