Events

Retiro De Equipo (Recall) de Meridian Hemodialysis Instrument

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
    36361
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0169-2007
  • Fecha de inicio del evento
    2006-09-06
  • Fecha de publicación del evento
    2006-11-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48483
  • 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
    Hemodialysis - Product Code KDI
  • Causa
    The meridian pump is less likely to detect small pressure changes, which may indicate the presence of a post-pump tubing kink, when using pre-pump arterial pressure monitoring.
  • Acción
    Urgent Device Correction letters dated 9/6/06 were sent to the Meridian accounts on the same date via UPS second day, to the attention of the Hemodialysis Administrator. The letters informed the accounts of the potential risk associated with a post-pump bloodline kink when using pre-pump arterial pressure monitoring. The accounts were provided with a revised Meridian Operator''s Manual which includes the following warnings: 'The lower venous limit should be set as close to the currently displayed venous pressure as conditions allow.' and 'Reliance on the pressure alarms should not substitute for clinical monitoring of the patient for adverse events.' Any technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 3, option 2, choice 2. General questions were directed to The Center for One Baxter at 1-800-422-9837.

Device

Meridian Hemodialysis Instrument
  • Modelo / Serial
    all serial numbers
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide and Hong Kong, Korea and China
  • Descripción del producto
    Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
  • 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