Events

Rappel de Device Recall HomeChoice and HomeChoice Pro Cyclers

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 Renal Div.

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
    58383
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2129-2011
  • Date de mise en oeuvre de l'événement
    2011-03-16
  • Date de publication de l'événement
    2011-05-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99244
  • 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
    Clinicians are being reminded of the current warning in the homechoice apd systems patient at-home guide, 07-19-61-244 (october 2,2009), which states on page 3-13 "to reduce the risk of bums, electrocution, fire, or injury to persons: close supervision is necessary when this product is used by, on, or near children or those unable to care for themselves." tubing entanglement around the neck may r.
  • Action
    Baxter sent Safety Alert letters dated March 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to consider the following safeguards for at-risk patients on HomeChoice Therapy: Have a caregiver present while the patient is performing therapy. Move the HomeChoice cycler to the foot of the bed, if possible, to minimize the likelihood of entanglement that may lead to asphyxiation. Install bed railings for patients at risk for seizures or falls from bed. Complete the attached customer reply form and fax it to Baxter at t847-270-5457. For questions regarding this recall call 888-736-2543, option 2.

Device

Device Recall HomeChoice and HomeChoice Pro Cyclers
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AZ, CA, CT, DC, FL, KY, MO, NC, NM, Ny, OH, PA, TN, TX, and VA and the countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, India, Iraq, Ireland, Israel, Italy, South Korea, Kuwait, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russia, South Africa, Saudi Arabia, Singapore, Slovania, Spain, Sweden, Switzerland, Thailand, Taiwan, Tunisia, Turkey, United Arab Emirates, United Kingom, and Venezuela.
  • Description du dispositif
    APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Adresse du fabricant
    Baxter Healthcare Renal Div, 1620 Waukegan Rd, Mc Gaw Park IL 60085-6730
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA