Events

Retiro De Equipo (Recall) de Device Recall Colleague CX Infusion Pump

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 Corp..

¿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
    59270
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2853-2011
  • Fecha de inicio del evento
    2011-07-05
  • Fecha de publicación del evento
    2011-07-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-01-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102087
  • 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
    Pump, infusion - Product Code FRN
  • Causa
    While replacing a defective pump head mechanism and performing calibration, baxter's service center may have failed to apply glyptol (a red insulating varnish) on a potentiometer that helps maintain pump accuracy for detecting an air bolus.
  • Acción
    Baxter Healthcare Corporation telephoned its customers on July 1, 2011 and sent a follow up "URGENT PRODUCT RECALL" letter dated July 6, 2011, informing them that the Glyptol (a red insulating varnish) may not have been applied on the Air-In-Line (AIL) circuit board. The letter described the product, problem and actions to be taken. The customers were instructed to locate the affected pumps, remove from service and return to Baxter for inspection as soon as possible. If GLYPTOL is found to be missing, recalibration will be performed and GLYPTOL will be applied per requirement before returning the pumps back to the customer at no cost. The customer was instructed to complete and sign the attached customer reply form. The letter states that if the COLLEAGUE Pumps were distributed to other facilities, please forward communication to the pump owner as appropriate. For any questions contact The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm Central Time, Monday through Friday.

Device

Device Recall Colleague CX Infusion Pump
  • Modelo / Serial
    Product Code: 2M8161, Lot Numbers 13060235CC and 13090748CC
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide (USA) Distribution -- including the state of Pennsylvania.
  • Descripción del producto
    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Code: 2M8161. || Product Usage: Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients. Electronic infusion pumps indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA