Events

Rappel de Device Recall Sarns 8000 Roller 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
    57241
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0563-2011
  • Date de mise en oeuvre de l'événement
    2010-11-02
  • Date de publication de l'événement
    2010-12-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95648
  • 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, roller type - Product Code JOR
  • Cause
    The system 8000 roller pumps may fail resulting in a persistent pump stop.
  • Action
    The firm sent "URGENT MEDICAL DEVICE CORRECTION" dated 11/02/2010 to customers. The letter describes the product, problem and corrective actions taken and/or needed to be taken by the customers. The letter states the system responds to a failed inductor by displaying an overspeed message and stopping the roller pump without an audible alert. The pump cannot be restarted. The customers/users are instructed to stop the pump, replace the pump with a backup or if necessary use the handcrank. The letter states that Terumo will replace the roller pump at the next preventative maintenance visit - or sooner- if the customer has a service contract. If the customer does not have a service contract, Terumo will contact the customer within 2 weeks to set up an appointment for the service. Terumo CVS expects all affected inductors to be replaced to be replaced within three months. Call Terumo CVS Customer Service upon completion of the case at 800-521-2818. The customer was also instructed to complete and return the enclosed CUSTOMER RESPONSE FORM Please note that we are not recommending that you stop using the roller pumps for your Sarns system 8000. For any questions, call toll free 800-262-3304 or phone 734-663-4145.

Device

Device Recall Sarns 8000 Roller pump
  • Modèle / numéro de série
    Lots 19937-19944, 19955-19984, 20005-20029, 20035-20038 and 20047.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA including states of CA, FL, NC and NY and countries of United Arab Emirates, China, Ecuador, and Panama.
  • Description du dispositif
    Sarns 8000 Roller pump for Sarns System 8000 Heart Lung Machine console, 220V, Catalog No 16407, Terumo Cardiovascular System Corp Ann Arbor, MI. (not distributed in the US) || The system 8000 is indicated for use in extracorporeal circulation of blood for arterial perfusion, reginal perfusion and cardiopulmonary bypass procedures.
  • 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