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
    62367
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1968-2012
  • Date de mise en oeuvre de l'événement
    2012-06-25
  • 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
    2015-09-18
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110339
  • 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) has received reports of various roller pump occlusion malfunctions that could result in the inability to use the pump and would then require replacement with back-up equipment. occlusion malfunctions include stiff/difficult to adjust occlusion, loss of occlusion setting, unequal roller-to-roller occlusion and inability to adjust the occlusion. if it is.
  • Action
    The firm, Terumo, sent an "URGENT MEDICAL DEVICE RECALL" notification dated June 25, 2012 and an update to the Operator's Manual for the Terumo Advanced Perfusion System 1 via Federal Express to its customers. The notification describes the product, problem and actions to be taken. The customers were instructed to review this Medical Device Recall notice; assure that all users are aware of this notice; place the addendum at the beginning of the Roller Pumps Section (page 5.1) of the Operator's Manual, and complete and return the attached Customer Response Form to the fax number/email address indicated on the form. Note: Terumo is continuing its investigation into the root cause of the malfunctions, and may initiate further action pending results of the investigation. If you have any questions or concerns, contact Terumo CVS Customer Service at 1-800-521-2818; 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 and serial numbers: 0011-0335, 0337-0610, 1001-1034, 1037-1049, 1100, 1103-1106, 1109-1445, and 1447-1450.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Germany, 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
    System 1 Base 100/120V || 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.
  • 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