Events

Retiro De Equipo (Recall) de Device Recall HomeChoice PRO

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
    30693
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0397-05
  • Fecha de inicio del evento
    2004-12-23
  • Fecha de publicación del evento
    2005-01-15
  • 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=36407
  • 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 was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, Peritoneal, Automatic Delivery - Product Code FKX
  • Causa
    A software anomaly may allow concentrated solution to be infused into the patient when the homechoice unit is used with physioneal clear-flex pd products.
  • Acción
    Baxter notified the Danish Ministry of Health of the problem with the HomeChoice Pro not prompting the patient when using the Physioneal Clear-Flex PD products on 12/23/04. The patients in Denmark and Sweden will be re-evaluate and re-train each patient as needed using enhanced training materials, which will include the importance of and the rationales for breaking the peel-seal on teh Physioneal ClearFlex prior to use and what to do if mis-infusion occurs. Larger, adhesive, colored stickers will be affixed to all applicable HomeChoice Pro machines to further remind patients of the need to break all peel-seals prior to use. Patients will receive a new Pro-Card when their machine is exchanged, and the exchange will be documented. The HomeChoice Pro software will be updated to correct the software anomaly, validated and installed on the HomeChoice Pro machines.

Device

Device Recall HomeChoice PRO
  • Modelo / Serial
    Units with software version 8.7 used with Physioneal Clear-Flex PD products
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Those HomeChoice units in Denmark and Sweden only, where the Physioneal Clear-Flex products are approved for use.
  • Descripción del producto
    HomeChoice PRO Automated 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
  • 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