Events

Rappel de Device Recall Baxter Healthcare Corporation

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
    71818
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0291-2016
  • Date de mise en oeuvre de l'événement
    2015-06-29
  • Date de publication de l'événement
    2015-11-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139148
  • 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
    System, peritoneal, automatic delivery - Product Code FKX
  • Cause
    Loud operating sounds, which was unacceptable to the end users when the device was powered on. the homechoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. may delay treatment if changing to a different system.
  • Action
    Baxter sent an Important Product Information communication to affected customers (patients and clinicians) via U.S.P.S., first-class mail on June 29, 2015. The letter states that Baxter Healthcare Corporation is updating the HomeChoice Patient At-Home Guide to include a discussion of the expected operating sounds associated with the HomeChoice and HomeChoice PRO devices. The new labeling will address the following: The HomeChoice cycler utilizes an air (pneumatic) pump; some sounds related to the operation of this pump are expected as part of normal operation of the HomeChoice cycler. There will be sounds like humming, swishing, clicking, and venting (air being released) that are normal for the operation of the cycler. In certain portions of the therapy, the sound level is expected to increase which is also part of normal operation. If there is a significant change in the sound level or a new, previously unheard sound when using the HomeChoice cycler, please contact your doctor and/or nurse or Baxter Technical Services. The firm advises customers to keep the letter with the Patient At-Home Guide. The firm also requests that customers complete the enclosed home patient reply form (enclosure) and return it to Baxter by faxing the reply form to 224-270-5457, scanning and e-mailing it to fca@baxter.com or by mail in the enclosed, preaddressed, stamped envelope. Returning the home patient reply form promptly will prevent you from receiving repeat notices. If the customer has any questions about their Peritoneal Dialysis (PD) therapy, they are advised to please contact their doctor and/or nurse. Additionally the letter states that any adverse reactions or quality problems experienced with the use of this product may be reported using one of the following options: " Calling Baxter Product Surveillance at 800-437-5176, Monday through Friday, between 8:00 am and 5:30 pm Central Time Baxter will advise customers of the additional product information regarding

Device

Device Recall Baxter Healthcare Corporation
  • Modèle / numéro de série
    All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R.   Dates Distributed: 1994 to present  Quantity Distributed: All
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution, District of Columbia, and Puerto Rico.
  • Description du dispositif
    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
  • 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