Events

Rappel de Sarns" Centrifugal System

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
    63079
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0049-2013
  • Date de publication de l'événement
    2012-10-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112481
  • 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
    Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
  • Cause
    Terumo cardiovascular systems (terumo cvs) has received multiple reports since 2004 of various malfunctions of the battery backup system for the sarns" centrifugal system. the reports can be broadly categorized as follows: " failure to charge " failure to hold charge " failure to operate in the most severe case, a battery malfunction could result in an unexpected loss of arterial flow. in.
  • Action
    TERUMO sent an Urgent Medical Device Recall letter dated June 25, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. On 09/25/2012 an URGENT MEDICAL DEVICE RECALL notification and addendum was sent to all consignees. TCS issued this notification as a Safety Advisory to alert all users of the Sarns centrifugal system of the potential for malfunction and remind them to review the appropriate sections of the Operators Manual for the Sarns Delphin Battery. Providing an addendum to the Operators Manual for the Sarns Delphin Battery with additional instruction on the use and charging of a discharged battery. Customers were instructed to review the Medical Device Recall notice; assure that all users are aware of the notice; place the addendum in the Operator's Manual; and confirm receipt of the communication by faxing or emailing the attached Customer Response Form. For questions customers were instructed to call 1-800-521-2818. For questions regarding this recall call 734-741-6173.

Device

Sarns" Centrifugal System
  • Modèle / numéro de série
    Catalog number: 9490; and lot numbers: 0101,1001-1025,1188-1192,1997, 2000-2017, 2019- 2082, 2086-2287, 2290-2446, 2452-2633, 2636-2938, and 2946-3063
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, UT, VA, WA, WI, and WV. Puerto Rico and internationally to: ALEXANDRIA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BELGIUM, BRAZIL, CANADA, CENTRO AMERICA, CHILE, COLOMBIA, Dominican Republic, Ecuador, FRANCE, GERMANY, GREECE, Guatamala, HOLLAND, HONG KONG, India, ITALY, Japan, KL SEGUNDO, KOREA, LEICESTERSHIRE, MALAYSA, Malaysia, Mexico, Mexico, Mexico, NETHERLANDS, Panama, Peru, Philippines, RALEIGH, Republic of Georgia, SANTIAGO CHILE, Saudi Arabia, SEOUL KOREA, SHANGHAI, CHINA, Singapore, South Africa, SPAIN, SWITZERLAND, TAIWAN, Thailand, UNITED ARAB EMIRATES (UAE), Uruguay, USA, and Venezuela,
  • Description du dispositif
    Battery, 100/115V (Includes charger and connecting cable) || The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
  • 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