Events

Rappel de Device Recall Alaris Pump Module 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
    75466
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0950-2017
  • Date de mise en oeuvre de l'événement
    2016-12-02
  • Date de publication de l'événement
    2017-01-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-07-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150442
  • 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
    During an infusion, a false air-in-line (ail) alarm would cause the infusion to be interrupted.
  • Action
    Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related questions were instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F or email supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24 hrs/day, 7days/wk. or email customerfeedback@carefusion.com. For questions regarding this recall call 858-617-2000.

Device

Device Recall Alaris Pump Module 8100
  • Modèle / numéro de série
    All products manufactured or serviced in the time period October 2011 through June 2015.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. || 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 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