Events

Retiro De Equipo (Recall) de Device Recall Phoenix Monitor

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 Corporation.

¿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
    76168
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1094-2017
  • Fecha de inicio del evento
    2017-01-04
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152438
  • 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
    Baxter healthcare corporation is issuing a voluntary product recall for several lots of phoenix dialysis machine preventive maintenance kits due to incorrect silicone straight connectors components packaged in these kits. during preventive maintenance, the two silicone connectors must be installed in the phoenix mass-balance section of hydraulic circuit only if the phoenix machine has already been modified with "conn. improving retr. kit" (code sp00721). installation of these connectors in machines modified with sp00721 may result in fluid leaks during dialysis treatment. these preventive maintenance kits include the filter sub-group, which contains the silicone straight connectors that are larger than expected.
  • Acción
    Baxter sent an Urgent Product Recall on January 4, 2016, to all affected customers via U.S.P.S., first class mail. Customers were asked to: 1) Locate and remove all affected product lots from their facility. 2) Check if the Preventative Maintenance Kits were already installed in their Phoenix machines and if the case or if uncertain, contact their Baxter Service Representative at 1-800-525-2623 (Option 2) to schedule an appointment to remediate the machine. 3) Contact Baxter Health care Center for Service to arrange for return and credit. 4) Complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email. All non-responding customers will be contacted via telephone. All affected product will be destroyed or discarded. Customers with questions were advised to call 800-437-5176.

Device

Device Recall Phoenix Monitor
  • Modelo / Serial
    Product code: 6997266; Lot codes: 1607250, 160824D, 161005D, 161026D
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Maintenance Kit PH1, Cod. 6997266 || The Phoenix Hemodialysis delivery system is intended to be used to provide high flux and low flux hemodialysis, hemofiltration and ultrafiltration on patients weighing 15 Kilograms or more. The Phoenix system is to be used with either high or low permeability dialyzers. The device is intended to be used by trained operators when prescribed by a physician, in a chronic care dialysis facility or acute care unit
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Dirección del fabricante
    Baxter Healthcare Corporation, 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA