Events

Rappel de Alaris Pump Module model 8100

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 CareFusion 303, Inc..

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
    77987
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0026-2018
  • Date de mise en oeuvre de l'événement
    2017-08-09
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158454
  • 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, infusion - Product Code FRN
  • Cause
    The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
  • Action
    BD sent an Urgent: Medical Device Recall Notification dated September 1, 2017. The customer letter will instruct the customers to remove the pump from service if it shows signs of infusion at an unexpected rate and not to use the affected devices in high risk areas if possible. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to BD by postage-paid, self-addressed mail, fax, or email. For further questions, please call (888) 562-6018.

Device

Alaris Pump Module model 8100
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
  • Description du dispositif
    Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; || Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; || Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. || The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.
  • Manufacturer
    CareFusion 303, Inc.

Manufacturer

CareFusion 303, Inc.
  • Adresse du fabricant
    CareFusion 303, Inc., 10020 Pacific Mesa Blvd, San Diego CA 92121-4386
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA