Events

Retiro De Equipo (Recall) de Device Recall Baxter FloGard 6301 Dual Channel Volumetric Infusion Pumps

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
    38221
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1112-2007
  • Fecha de inicio del evento
    2007-06-21
  • Fecha de publicación del evento
    2007-07-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-03-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53176
  • 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
    Infusion Pumps - Product Code FRN
  • Causa
    Falsified repair/test and inspection records: pumps submitted for repair or service may not have been properly repaired or serviced before being returned to the customer.
  • Acción
    Baxter telephoned the direct accounts starting on 6/21/07, informing them that functional verification testing may not have been performed on their Flo-Gard and/or Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required functional verification testing. *** Baxter expanded the recall and telephoned the direct accounts starting on 7/30/07, informing them that the electrical safety testing may not have been performed on their Colleague infusion pumps before they were returned to them. Since Baxter has no evidence that this quality control testing was conducted on these pumps, the pumps may not function as designed. The accounts were requested to locate the affected pumps and take them out of service as soon as possible, and send them back to Baxter for the required electrical safety and all functional verification testing. Follow-up recall letters were sent to the accounts on 8/7/07 reiterating the telephone conversations and providing a list affected pump serial numbers to be removed from service and returned to Baxter for testing. They were also requested to report any malfunction or adverse event related to the Colleague or Flo-Gard Infusion Pumps to Baxter Corporate Product Surveillance at 1-800-437-5176. ****Recall 2 Extension******* Baxter expanded the recall for a second time via letter on 8/20/07 and telephone calls starting on 8/21/07, informing the direct accounts that Baxter's investigation found documentation inconsistencies by three more of their service technicians, representing the possibility of incomplete testing and/or documentation by these technicians who serviced Colleague infusion pumps at the account's facility. Without complete and properly do

Device

Device Recall Baxter FloGard 6301 Dual Channel Volumetric Infusion Pumps
  • Modelo / Serial
    product code 2M8064, serial numbers RA00449, RA00771, RA01093, RA01103FA, RA01143, RA01212FA, RA01241FA, RA01352, RA01392, RA01471FA, 4020417FA, 4110026FA, 4110599FA, 4111648FA, 5010398FA, 5010588FA, 5010892FA, 5030542FA, 5031363FA, 5041317FA, 5041836FA, 5050032FA, 5101954FA, 5111071FA, 5111215FA, 5111217FA, 6020538FA, 6051302FA, 6110083FA, 6110621FA, 6110976FA, 6112818FA, 6113536FA, 6120726FA, 6120952FA, 6121014FA, 6121201FA, 6121249FA, 62004506, 62009976,62013806, 62020266, 62067349, 62069349, 6208698X, 63106801, 63111022, 63111672, 63157766, 63159996, 63173758, 7120494FA, 8020914FA, 8030070FA, 8060094FA, 8080471FA, 8090732FA, 8090762FA, 8111587FA, 8111640FA, 83003592, 83039198, 83044518, 83055250, 83064210, 83069140, 9030584FA, 9030593FA, 9110819FA, 10091327FA, 10091426FA,10091428FA, 10110600FA, 10111225FA, 10111396FA, 10112596FA, 10113463FA, 10113550FA, 10113557FA, 10120142FA, 11030108FA, 11030281FA, 11030908FA, 11031331FA, 11042552FA, 11042740FA, 11042815FA, 11051333FA, 11052654FA, 11052741FA, 11052809FA, 11052957FA, 11061064FA, 11070997FA, 11072099FA, 11081754FA, 11100082FA, 11111119FA, 11120281FA, 11120313FA, 11120327FA, 11120346FA, 12020834FA, 12010409FA, 12031733FA, 12040163FA, 12041054FA, 12060362FB, 12060972FA, 12061359FA, 12061727FA, 12070800FA, 12080863FA, 12090274FA, 12100402FA, 12101819FA, 12102195FA, 12102656FA, 12102742FA, 12102862FA, 12120472FA, 12121033FA, 13010030FA, 13010283FA, 13070260FA, 13070316FA, 13080047FA, 13100967FA, 13101196FA, 13110190FA, 14010668FA, 14050871FA, 14071117FA, 14071128FA, 14071153FA, 14071166FA, 14091581FA, 14091796FA, 14020391FA, 14020002FA, 15013155FA, 15013208FA, 15050126FA, 15050608FA.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide: Alaska, Arizona, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maryland, Michigan, Mississippi, Montana, Nebraska, Nevada, New Jersey, New Mexico, New York, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wyoming
  • Descripción del producto
    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product code # 2M8064
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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