Rappel de Device Recall Control panel for mast roller pump 150/85

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 Sorin Group Deutschland GmbH.

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
    61375
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1327-2012
  • Date de mise en oeuvre de l'événement
    2012-02-23
  • Date de publication de l'événement
    2012-03-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2012-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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
    The pump speed control knob is attached to the shaft of an encoder that is used to adjust the speed. insufficient lubrication within the encoder increases friction over time making it more difficult to turn the pump speed control knob. excessive friction causes premature wear of the encoder shaft which can result in a stuck shaft.
  • Action
    Sorin Group sent an Urgent Field Safety Notice dated February 23, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: Before each use of the device during the set-up procedure, rotate all pump speed control knobs back and forth to check for smooth operation. If abnormal friction or any binding is detected, please do not use the system until it is repaired. If an affected product is currently in use with a patient and an increase of friction is detected please prepare for a replacement pump. Please complete and return the attached Confirmation Form by fax to 303-467-6502. Customers were instructed to ensure that the Urgent Field Safety Notice is distributed to all personnel in their organization who need to be aware of the notice. If the product was transferred to a third party, customers were asked to share the information with them as well as Sorin Group USA Customer Service at 1-800-850-2623. For questions regarding this Urgent Field Safety Notice, contact Sorin Group USA Customers Service at 1-800-650-2623. All affected customers and distributors were notified of the Field Correction by certified mail beginning on February 23, 2012. They will be contacted by Sorin Service Group to arrange an appointment to replace affected shaft encoders on site.

Device

  • Modèle / numéro de série
    50E60413 to 50E60518
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution
  • Description du dispositif
    Control panel for mast roller pump 150/85 || The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Sorin Group Deutschland GmbH, Lindberghstrasse 25, Munchen Germany
  • Société-mère du fabricant (2017)
  • Source
    USFDA