Events

Rappel de Device Recall Pyxis

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 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
    53991
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1015-2013
  • Date de mise en oeuvre de l'événement
    2009-11-20
  • Date de publication de l'événement
    2013-03-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-03-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86996
  • 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
    Cabinet, table and tray, anesthesia - Product Code BRY
  • Cause
    The recall was initiated because carefusion has confirmed that when the pas 2000 drawers due to inaccessability of drawers caused by system down time or lock-up.
  • Action
    Carefusion sent a Safety Alert Notification letter dated January 13, 2010 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to ensure back-up procedures were in place in case of system down-time or lock-up, including review of the back-up procedures with staff. The letter included an update to the PAS 2000 User Guide. The letterstates that a CareFusion field representative will be contacting customers to make arrangements to apply warning labels to the PAS 2000 electronics doors. Customers were instructed to complete and return the Response Card included. For questions contact your local field support representative ot the Advocacy department at customer.advocacy@carefusion.com.

Device

Device Recall Pyxis
  • Modèle / numéro de série
    All Pyxis Anesthesia System Model 2000
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) including CANADA.
  • Description du dispositif
    Pyxis Anesthesia System Model 2000 (PAS 2000) || Product Usage: The PAS 2000 is an anesthesia medication dispensing device that provides medications and inventory management for the anesthesiologist at the point of care within the operating room.
  • Manufacturer
    CareFusion Corporation

Manufacturer

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