Events

Retiro De Equipo (Recall) de Covidien Kangaroo Connect Enteral Feeding 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 Medtronic.

¿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
    73669
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1648-2016
  • Fecha de inicio del evento
    2016-04-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144698
  • 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, enteral - Product Code LZH
  • Causa
    Kangaroo connect feeding pump occlusion alarms fail to alarm.
  • Acción
    Medtronic(formerly) Covidien notified accounts via Urgent Medical Device Recall letter, dated 4/1/16, that specific serial numbers with software versions 1.12 and 1.13 have a software anomaly. The firm shipped replacement units with software V 1.14. Affected devices must be returned to the firm once the replacement units have been received. A Recalled Product Return Form required to be completed and returned. Questions or concerns, contact Medtronic representative or Customer Service at (800) 882-5878.

Device

Covidien Kangaroo Connect Enteral Feeding Pump
  • Modelo / Serial
    Serial Numbers: AS1500000614 AS1500000615 AS1500000620 AS1500000621 AS1500000628 AS1500000630 AS1500000631 AS1500000633 AS1500000637 AS1500000638 AS1500000639 AS1500000640 AS1500000641 AS1500000643 AS1500000680 AS1500000681 AS1500000683 AS1500000685 AS1500000686 AS1500000687 AS1500000694 AS1500000695 AS1500000696 AS1500000697 AS1500000698 AS1500000699 AS1500000702 AS1500000703 AS1500000814 AS1500000820 AS1500000823 AS1500000824 AS1500000826 AS1500000827 AS1500000828 AS1500000830 AS1500000831 AS1500000833 AS1500000836 AS1500000837 AS1500000839 AS1500000842 AS1500000843 AS1500000845 AS1500000847 AS1500000849 AS1500000850 AS1500000852 AS1500000854 AS1500000856 AS1500000857 AS1500000858 AS1500000859 AS1500000860 AS1500000861 AS1500000862 AS1500000863 AS1500000866 AS1500000869 AS1500000872 AS1500000873 AS1500000874 AS1500000875 AS1500000876 AS1500000880 AS1500000883 AS1500000885 AS1500000887 AS1500000889 AS1500000891 AS1500000892 AS1500000894 AS1500000895 AS1500000896 AS1500000897 AS1500000898 AS1500000901 AS1500000902 AS1500000903 AS1500000904 AS1500000906 AS1500000907 AS1500000909 AS1500000911 AS1500000912 AS1500000913 AS1500000915 AS1500000916 AS1500000917 AS1500000921 AS1500000922 AS1500000923 AS1500000924 AS1500000925 AS1500000926 AS1500000927 AS1500000928 AS1500000929 AS1500000930 AS1500000932 AS1500000933 AS1500000934 AS1500000935 AS1500000936 AS1500000941 AS1500000942 AS1500000947 AS1500000948 AS1500000951 AS1500000952 AS1500000955 AS1500000970 AS1500000974 AS1500000975 AS1500000976 AS1500000977 AS1500000978 AS1500000979 AS1500000981 AS1500000996 AS1500000998 AS1500001002 AS1500001009 AS1500001044 AS1500001045 AS1500001058 AS1500001061 AS1500001069 AS1500001075 AS1500001084 AS1500001125 AS1500001134 AS1500001137 AS1500001145 AS1500001146 AS1500001148 AS1500001149 AS1500001151 AS1500001158 AS1500001163 AS1500001166 AS1500001171 AS1500001172 AS1500001175 AS1500001178 AS1500001180 AS1500001182 AS1500001188 AS1500001190 AS1500001191 AS1500001192 AS1500001199 AS1500001235 AS1500001236 AS1500001237 AS1500001240 AS1500001242 AS1500001243 AS1500001244 AS1500001245 AS1500001246 AS1500001247 AS1500001249 AS1500001250 AS1500001251 AS1500001252 AS1500001253 AS1500001256 AS1500001259 AS1500001260 AS1500001262 AS1500001263 AS1500001265 AS1500001267 AS1500001268 AS1500001269 AS1500001272 AS1500001273 AS1500001274 AS1500001275 AS1500001277 AS1500001279 AS1500001280 AS1500001281 AS1500001282 AS1500001283 AS1500001289 AS1500001292 AS1500001295 AS1500001296 AS1500001302 AS1500001303 AS1500001308 AS1500001309 AS1500001310 AS1500001312 AS1500001313 AS1500001317 AS1500001323 AS1500001324 AS1500001325 AS1500001326 AS1500001333 AS1500001334 AS1500001335 AS1500001336 AS1500001347 AS1500001370 AS1500001397 AS1500001403 AS1500001410 AS1500001421 AS1500001441  AS1500001450  AS1500001451  AS1500001455  AS1500001456  AS1500001466  AS1500001467  AS1500001472  AS1500001473  AS1500001474  AS1500001623
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution -- USA, Australia, Canada, France, and Singapore.
  • Descripción del producto
    Covidien Kangaroo Connect Enteral Feeding Pump || Item Number: 384400 (US) || Intended to provide enteral nutrition to a patient for hospital and acute care settings.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Dirección del fabricante
    Medtronic, 60 Middletown Ave, North Haven CT 06473-3908
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA