Events

Rappel de Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump

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
    76386
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1235-2017
  • Date de mise en oeuvre de l'événement
    2015-05-27
  • Date de publication de l'événement
    2017-02-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153034
  • 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 corporation has received complaints indicating that the sarns centrifugal pump (disposable pump heads) have exhibited leaks. the leaks were detected during priming of the bypass circuit and during cpb procedures. in each of the reported incidents, there were no reports of patient injury as a result of the centrifugal pump leaks. terumo cardiovascular system's investigation into the incident has identified the cause of the leaks to be cracks in both the top housing and magnet back housing of the pump. when the cracks cause the housing to become compromised, it is possible for fluid to leak from the pump head.
  • Action
    Customer Notification Letter/Response Form is being sent to all affected consignees.

Device

Device Recall Centrifugal Pumphead, Cardiovascular Procedure Kit with Centrifugal Pump
  • Modèle / numéro de série
    TAOS, TC03
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Terumo CVS has identified 33 domestic consignees and 0 international consignee that are affected by this recall
  • Description du dispositif
    The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Terumo location for inclusion in Cardiovascular Procedure Kits. Cardiovascular Procedure kits are packaged individually.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Adresse du fabricant
    Terumo Cardiovascular Systems Corporation, 125 Blue Ball Rd, Elkton MD 21921-5315
  • Société-mère du fabricant (2017)
    Terumo Corp.
  • Source
    USFDA