Events

Rappel de Device Recall 220/240V AC, Advanced Perfusion System Platform (APS)

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
    63543
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0436-2013
  • Date de mise en oeuvre de l'événement
    2012-11-14
  • Date de publication de l'événement
    2012-11-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114180
  • 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 system (tcvs) has received reports of a situation where users experienced a total loss of functionality for some system 1 units. the reports indicate that the units went blank and shut down with no sign of power and battery backup did not initiate. the result is all pumps stop, with no safety system functionality, and the battery would not be activated. the user would be.
  • Action
    Terumo Cardiovascular Systems sent a Urgent Medical Device Recall Correction letter dated November 14, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Terumo CVS is alerting all users of Terumo System 1 of the reports of malfunction. Customers were instructed to: 1. Review this Medical Device Safety Advisory. 2. Assure that all users are aware of this notice. 3. Confirm receipt of this communication by faxing, or emailing the attached Customer Response Form to the fax number/email address indicated on the form. We encourage you to contact us with any questions or concerns: Terumo CVS Customer Service 1-800-521-2818, Recall Fax 1-734-741-6149 Customer Service Hours: Monday thru Friday, 8 AM - 6 PM ET

Device

Device Recall 220/240V AC, Advanced Perfusion System Platform (APS)
  • Modèle / numéro de série
    Catalog number: 801764 and all serial numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV.
  • Description du dispositif
    220/240V AC, Advanced Perfusion System Platform (APS) || 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