Events

Rappel de Device Recall 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
    77279
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2700-2017
  • Date de mise en oeuvre de l'événement
    2017-06-12
  • Date de publication de l'événement
    2017-06-19
  • 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=155608
  • 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
    There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the alaris pump module model 8100.
  • Action
    An Urgent Medical Device Recall letter will be sent on 6/12/17 to customers to inform them that BD is issuing this letter to inform you of a potential risk associated with the Alaris Pump module. Firm identified a specific scenario that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. This scenario is reproducible under the following situations: a) the user does not close the roller clamp on the IV administration set before the pump door is opened as recommended, and b) opening the pump door using an atypical technique with the door latch with the centered sear design. The letter instructs customers If their device has a centered-sear that was manufactured between June 2002 to June 2004, clearly mark and sequester (e.g. Biomed department) the Alaris Pump module that exhibited the issue. Notify CareFusion Customer Advocacy at 888-812-3266 or customerfeedback@carefusion.com to coordinate an onsite remediation or send the devices to the BD Service Depot.

Device

Device Recall Alaris Pump Module model 8100
  • Modèle / numéro de série
    Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US and Canada
  • Description du dispositif
    Alaris Pump Module model 8100
  • 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