Events

Retiro De Equipo (Recall) de Sigma Spectrum Infusion Pump component (LCD screen)

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
    66392
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0189-2014
  • Fecha de publicación del evento
    2013-11-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-11-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122243
  • 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
    Baxter healthcare corporation is recalling the lcd display screen on the sigma spectrum infusion pump with master drug library for not meeting standards for withstanding an electrostatic discharge.
  • Acción
    Baxter Healthcare Corporation sent an Urgent Product Recall letter dated September 24, 2013 to all affected customers via first class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate the affected product, remove them from use and acknowledge your receipt of the recall notification by completing the provided Customer Reply Form and fax to 224-270-5467. Customers were asked to contact Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday during the hourse of 7:00 am and 7:00 pm Eastern Time to order replacement device(s). For technical questions contact Baxter Healthcare Medina at 800-356-3454, (choose option1) and for clinical questions contact Medical Information Services at Baxter 800-933-0303.

Device

Sigma Spectrum Infusion Pump component (LCD screen)
  • Modelo / Serial
    Product Code: 35700BAX & 35700ABB; Serial Numbers: 433713, 435563, 704056, 707290, 715315, 724216, 740127, 752318, 752447, 753675, 754947, 759766, 765934, 770034, 772017, 773470, 776507, 781016, 781969, 783352, 783454, 787567, 789720, 791225, 794828, 794990, 797185, 804798, 808393, 808764, 810971, 812076, 818718, 821213, 824067, 824198, 839143, 850028, 850577, 852007, 852431, 855450, 860201, 864799, 876765, 877548, 877944, 878637, 879810, 879886, 880022, 884707, 884778, 885565, 889416, 889814, 890949, 890987, 894957, 895413, 896662, 896912, 897576, 900401, 904778, 913511, 915035, 915981, 916173, 916948, 919159, 921162, 921937, 922515, 923861, 945583, 953011, 953360, 953995, 955881, 959847, 967694, 978892, 981692, 986022, 997333, 998512, 1002325, 1018432, 1018436, 1018737
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide in the states of: AR, AZ, CA, CO, CT, FL, HI, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, TN, UT, VA, WA and WV and the country Canada.
  • Descripción del producto
    SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) || Product Usage: Intended to be used as a visual aid during the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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