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
    65354
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1968-2013
  • Date de mise en oeuvre de l'événement
    2013-07-26
  • Date de publication de l'événement
    2013-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118617
  • 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
    The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. specifically, if the user is adjusting the system 1 centrifugal pump speed via the central control monitor at the same time an alarm condition occurs with configuration for a pump coast response, the labeling in the operators manual does not fully describe how the pump will react.
  • Action
    Terumo CVS, sent an URGENT MEDICAL DEVICE RECALL notification letter dated July 26, 2013, to all affected customers explaining the correction to the operators manual, potential hazards and what to do in response to the issue. If you have any questions or concern please contact Terumo CVS Customer Service 1-800-521-2818 Recall Fax 1-734-741-6149 Customer Service Hours: Monday  Friday, 8 AM - 6 PM ET

Device

Device Recall Terumo Advanced Perfusion System 1
  • Modèle / numéro de série
    Catalog number: 801763
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the countries of Australia, Dubai, Hong Kong, Indonesia, Singapore, China, Mexico, British Columbia, Taiwan, Thailand, Chile, Malaysia, Japan, Belgium, United Arab Emirates (UAE), South Korea, Manila and Canada.
  • Description du dispositif
    Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 || 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 Rd, Ann Arbor MI 48103-9586
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA