Events

Retiro De Equipo (Recall) de Device Recall System 1000, TINA, AURORA and AltraTouch

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
    53139
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0179-2010
  • Fecha de inicio del evento
    2009-08-31
  • Fecha de publicación del evento
    2009-11-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-11-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84755
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Causa
    When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultrafiltration rate (ufr) to the minimum value as described in the operator's manual.
  • Acción
    Baxter sent an Urgent Device Correction letter dated August 31, 2009 to all System 1000 Series of Hemodialysis Instruments customers via first class mail on the same date, to the attention of the Hemodialysis Administrator. The letters informed the accounts that a software anomaly in software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 was discovered when the main power was lost temporarily during a simulated treatment. The anomaly prevents the instrument from automatically changing the ultrafiltration rate (UFR) to the minimum value as described in the Operator's Manual. The accounts were informed that instruments with software versions 4.B.0.9, 4.B.1.1 and 4.B.1.3 will be upgraded to version 4.B.1.4 software, provided the instruments have a 486 Motherboard or Single Board Computer, and that instruments containing versions of 4.A software are not affected. The accounts were requested to complete the enclosed Customer Reply form, indicating the instrument serial number and software version for each machine at the site, and if they would be requesting Baxter Technical Services to upgrade their instruments or have the software sent to them to make the upgrades, and fax the sheet to 1-847-270-5457. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 4, option 1.

Device

Device Recall System 1000, TINA, AURORA and AltraTouch
  • Modelo / Serial
    All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- United States (including Puerto Rico and the Virgin Islands), Algeria, Argentina, Austria, Bahrain, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, India, Indonesia, Ireland, Italy, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mauritania, Mexico, Morocco, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, Saipan, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay and Venezuela.
  • Descripción del producto
    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. || The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.
  • 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