Events

Retiro De Equipo (Recall) de Device Recall HomeChoice PRO & Yume Plus

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Baxter Healthcare Renal Div.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    29161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1013-04
  • Fecha de inicio del evento
    2004-05-24
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-12-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33235
  • Notas / Alertas
    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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notas adicionales en la data
    System, Peritoneal, Automatic Delivery
  • Causa
    A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. the possibility of an overfill can occur when the initial drain alarm volume is set to off and a change to the volume is made at the verify i-drain:xxxxml prompt.
  • Acción
    Urgent Device Correction letters dated 5/24/04 were mailed to the peritoneal dialysis nurse of facilities identified as having patients who use the HomeChoice machines. The letters informed them of the potential overfill problem and requested that they review the patient list provided with the letter and verify that it was complete. The nurses were requested to communicate the information to their home patients, and visit all of their patients who use the device in the low I-Drain Alarm Volume mode to make an interim correction, permanently changing the I-Drain Alarm Volume from OFF to 0ML in the Make Adjustments menu. Permanent software corrections will be installed when the revised software becomes available. Follow-up letters dated 1/12/05 were sent to the Home Care Coordinators, providing them with an addendum to the HomeChoice Trainer's guide, repeating the information from the 5/24/04 letter and providing additional information to safely disconnect from the HomeChoice system during therapy. The letters also included copies of the 1/14/05 letter sent directly to the HomeChoice home patients, as well as addenda to the Patient Help Cards and Patient At-Home Guide.

Device

Device Recall HomeChoice PRO & Yume Plus
  • Modelo / Serial
    All HomeChoice Systems with software versions 8.5 and higher.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide, Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Guatemala, Hong Kong, India, Ireland, Italy, Korea, Malaysia, Mexico, Nicaragua, the Netherlands, Peru, the Philippines, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela and the United Kingdom.
  • Descripción del producto
    HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Dirección del fabricante
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA