Events

Rappel de HX2 Temp Manage SYS 120V

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
    63344
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0278-2013
  • Date de mise en oeuvre de l'événement
    2012-10-16
  • Date de publication de l'événement
    2012-11-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113534
  • 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
    Controller, temperature, cardiopulmonary bypass - Product Code DWC
  • Cause
    Based on a retrospective review of quality data, ac control boards used in the manufacture of the hx2 temperature management system were identified as being manufactured using the incorrect flux material. use of the incorrect flux may contribute to premature board failure. a search of tcvs complaints revealed 3 complaints received related to the hx2 failure. each failure occurred during set up.
  • Action
    TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards. Customers with questions were instructed to call 1-800-621-2818. For questions regarding this recall call 734-741-6173.

Device

HX2 Temp Manage SYS 120V
  • Modèle / numéro de série
    Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
  • Description du dispositif
    HX2 Temp Manage SYS 120V || The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
  • 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