Events

Retiro De Equipo (Recall) de Device Recall 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
    65364
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1610-2013
  • Fecha de inicio del evento
    2013-06-07
  • Fecha de publicación del evento
    2013-06-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-06-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119120
  • 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
    Due to an increase in complaints for leaks at the distal male luer and luer cap. baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the luer.
  • Acción
    Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.

Device

Device Recall Infusion Pump
  • Modelo / Serial
    Product Codes: 2C1071KJP, 2C1073KJP, 2C1075KJP, 2C1080KJP, 2C1082KJP, 2C1955KJP, 2C1976KJ.  Expiration Dates: 06/30/13, 12/31/13, 06/30/14, 12/31/14
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.
  • Descripción del producto
    Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: || Single day Infusor 2 ml/h, || Single Day INFUSOR 2 ml/h System, || Half Day INFUSOR SV 5 ml/h System, || Two Day INFUSOR 2 ml/h System, || Two day Infusor 2 ml/h, || Multiday Infusor 0.5 ml/h, || Multiday INFUSOR 0.5ml/h System, || Seven Day Infusor 0.5 ml/h, || Seven Day INFUSOR 0.5ml/h System, Basal-Bolus Infusor-15min., Basal/Bolus INFUSOR 0.5 x 2 ml/h System with 15 Minute Lockout, Basal-Bolus Infusor || Device Listing: D018045 || The Multiday lnfusor. Seven Day lnfusor and the BasaVBolus lnfusor are indicated for patients requiring slow, continuous intravenous, intra-arterial, subcutaneous or epidural administration of medications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Dirección del fabricante
    Baxter Healthcare Corp., Route 120 And Wilson Rd, Round Lake IL 60073-9799
  • Empresa matriz del fabricante (2017)
    Baxter International
  • Source
    USFDA