Events

Retiro De Equipo (Recall) de Device Recall Baxter System 1000 Delivery System

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
    28375
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0583-04
  • Fecha de inicio del evento
    2004-02-20
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31719
  • 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, Dialysate Delivery, Sealed - Product Code FII
  • Causa
    These devices have the potential to overheat in the absence of a ground fault circuit interrupter (gfci). this heater system failure could result in a fire.
  • Acción
    Baxter sent urgent device correction letters dated 2/20/04 to the Hemodialysis Unit Administrators on the same date. The letters informed the accounts of the potential of a heater system failure that under specific conditions could lead to a fire. The letters listed the concurrent conditions that must exist for the potential overheating, and recommended that the following steps be taken to ensure the safety in operating the devices: 1) Plug these machine into GFCI outlets if available, and 2) If GFCI outlets are not available at the facility, the machines must be 'hard-powered off' after dialysis treatments are complete at the end of the day. The machine is had-powered off by placing the main power switch located in the back of the machine into the OFF position. If the facility typically performs a heat clean cycle of machines after treatments are completed, it is imperative that the machines are hard powered off at the completion of the cycle. Any questions were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 1, Monday through Friday, 8:30 AM to 6:00 PM EST.

Device

Device Recall Baxter System 1000 Delivery System
  • Modelo / Serial
    Serial numbers 1001S to 1142S; 50001 to 52109; 01001 to 26231
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    The devices were distributed nationwide and internationally to Baxter subsidiaries in Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Denmark, Ecuador, Finland, France, Republic of Georgia, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Lebanon, Morocco, Malaysia, the Netherlands, Oman, Panama, Preu, Philippines, Poland, Palestine, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Tunisia, Turkey and United Kingdom.
  • Descripción del producto
    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA
  • 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