Events

Retiro De Equipo (Recall) de Device Recall Baxter Auto Syringe AS50 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
    34580
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0612-06
  • Fecha de inicio del evento
    2006-02-07
  • Fecha de publicación del evento
    2006-03-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44132
  • 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
    A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm.
  • Acción
    Baxter sent Urgent Device Correction letters dated 2/7/06 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for the affected pumps to be susceptible to electro-static discharge, which could increase the potential to fail during use, causing the pump to stop infusing and issue an audible and visual alarm. The accounts were asked to immediately take the pump out of service, contact Baxter at 1-800-843-7867 to arrange for the return of the pumps in order to replace the non-conforming gasket, and complete and return the enclosed reply form confirming receipt of the letter. Any questions were directed to the Center for One Baxter at 1-800-422-9837.

Device

Device Recall Baxter Auto Syringe AS50 Infusion Pump
  • Modelo / Serial
    serial numbers 15060001AB, 15060002AB, 15060004AB/15060013AB, 15060015AB/15060021AB, 15060023AB/15060073AB, 15060075AB, 15060077AB/15060116AB, 15060116AB, 15060118AB/15060126AB, 15060128AB/15060130AB, 15060132AB/15060172AB, 15060174AB/15060209AB, 15070003AB/15070006AB, 15070008AB/15070018AB, 15070021AB, 15070023AB, 15070026AB/15070034AB, 15070037AB15070041AB, 15070044AB/15070047AB, 15070049AB/15070052AB, 15070056AB/15070059AB, 15070066AB, 15070069AB, 15070071AB, 15070072AB, 15070076AB, 15070077AB, 15070079AB, 15070081AB, 15070082AB, 15070084AB, 15070086AB, 15070087AB, 15070092AB, 15070094AB/15070096AB, 15070099AB, 15070101AB, 15070109AB, 15070111AB/15070115AB, 15070117AB, 15070119AB, 15070121AB, 15070122AB, 15070124AB, 15070126AB/15070128AB, 15070130AB/15070132AB, 15070138AB/15070140AB, 15070144AB
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide. Arizona, California, Florida, Georgia, Hawaii, Iowa, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Texas, Virginia, Washington, West Virginia
  • Descripción del producto
    Baxter Auto Syringe AS50 Infusion Pump, product code 1M8550; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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