Events

Rappel de Device Recall FOLFUSOR SV Elastomeric Infusion Devices

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 Baxter Healthcare Corp..

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
    65577
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1679-2013
  • Date de mise en oeuvre de l'événement
    2009-07-31
  • Date de publication de l'événement
    2013-07-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119649
  • 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, elastomeric - Product Code MEB
  • Cause
    There are reported incidents of leakage on the infusor and folfusor pumps at the connection of the blue winged cap and the distal male luer. investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged luer cap) and stored for a period of time, typically overnight. in addition, the reported instances of leakage.
  • Action
    Baxter sent an "Important Product Information" notification dated July 31, 2009, with a follow-up "Important Product Information" notification mailed on March 5, 2010. The notifications informed customers of the potential issue, and included instructions to ensure that the winged Luer cap is tightly secured after filling and priming. Customers were also instructed to follow normal clinical practices to reduce contact with any leaking medication, and to store pumps with pre-dispensed medication in a sealed pouch. If customers noticed a leak they were instructed to place the pump in a plastic bag, quarantine the device and call Baxter's Corporate Product Surveillance at 1-800-437-5176 for further instructions. Customers were asked to return the attached reply form via FAX to 1-847-270-5457. If customers further distributed the affected product they were instructed to forward the notification to other facilities. Customers with questions were instructed to call 1-800-933-0303. For questions regarding this recall call 224-270-4667.

Device

Device Recall FOLFUSOR SV Elastomeric Infusion Devices
  • Modèle / numéro de série
    *** 1) Product Code: 2C4700K; Lot: 09A014
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
  • Description du dispositif
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. || The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA