Events

Alerta De Seguridad para Infusion Pump, Intravascular Gravity Management Equipment: (1) Baxter Compatible Primary ADDitIV, (2) Baxter Compatible with Clave, (3) Baxter Compatible with SafeLine, (4) Horizon Key, Primary Key ADDitIV, (7) Horizon Primary ADDitIV, (8) Intelligent Primary ADDitIV, (9) Primary ADDitIV, (10) SafeLine Horizon, (11) SafeLine Primary ADDitIV, (12) SafeLine Horizon .. Catalogs No .: CC1270, CC1290, CC3130, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, NF3140D, NF3140D, NF3160, NF6413, SS3140, SS3160, SS6413, US3131, V1443, V1444-12, V1445, V1445-24, V1445- 30, V1445-44, V1446, V1447, V1449-12, V1452, V1453, V1464, V1484, V1485, V1785, V6410, V6413, V6430, V7210, V7410, V7410-10; Lots Nos .: 60053136, 60060567, 60060614, 60060630, 60060632, 60063769, 60063769, 60064892, 60067686, 60068313, 60070114, 60070183, 6007053, 60070903, 60070921, 60071429, 60071430, 60072370, 60073185, 60074375, 60074376, 60075964, 60075964, 60076654, 60076654, 60076654, 60076654, 60076560, 60076655, 60076655, 60076679, 60076746, 60076757, 60078427, 60078438, 60078439, 60078445, 60078455, 60078455, 60078853, 60078918, 60079388, 60081052, 60082545, 60082630, 60083980, 60083980, 60083980, 60083980, 60083980, 60083983, 60083983, 60083983, 60083983, 60084058, 60084058, 6008404, 60088341, 60088485, 60088577, 60088695, 60088855, 60088868, 60088866, 60088868, 60088868, 60088873, 60088876, 60088928, 60089309, 60089313, 60089328, 60089732, 60090119, 60090115, 60091137, 60091140, 60091150, 60091150, 60091162, 60091458 through 60091460, 60091463, 60091467, 60091470, 60091470, 60091474, 60092542, 60092686, 60092733, 60093306, 60093307, 60093309, 60093313, 600933 60093800, 60093600, 60093600, 60093659, 60093659, 60093659, 60093659, 60093881, 60093881, 60093881, 60093881, 60093883, 60095083, 60095252, 60095729, 60095813, 60095813, 60095830, 60095835, 60095835, 60095845, 60095848, 60095848, 60095850, 60096116, 60096176, 60096176, 60096199, 60096206, 60097237, 60097397, 60097397, 60097397, 60097616, 60097616, 60097636, 60097695, 60097697, 60097699, 60097773, 60097711, 60097723, 60097725, 60097727, 60097727, 60098003, 60098007, 60098066, 60098085, 60098092, 60098098, 60098141, 60098218, 60099589, 60102360, 60102330, 60102560, 60102647, 60101301, 60101301, 60101732, 60101732, 60101732, 60102321, 60102321, 60102321, 60102301, 60102654, 60102654, 60102656, 60102656, 60102756, 60102717, 60103171, 60103174, 60103910, 60104238, 60104406, 60104246, 60104249, 60104249, 60104261, 60104267, 60104269, 60104272, 60104883, 60104929, 60105356, 60105370, 60105372, 6010 60107640, 60106045, 60106045, 60106045, 60106064, 60106064, 60106064, 60106609, 60106609, 60106142, 60106772, 60107539, 60107540, 60107540, 60107610, 60107610, 60107990, 60107937, 60107938, 60109024, 60109986, 60111419, 60111420, 60111422, 60111430, 60111434, 60111434, 60111436, 60111464, 60111464, 60111468, 60111267, 60111264, 60111269, 60111264, 60111264, 60113266, 60113268, 60113272, 60113281, 60113281, 60113285, 60113371, 60113389, 60113391, 60113394, 60113394, 60113396, 60113397, 6011347, 60113512, 60113514, 60113517, 60113517, 60113764, 60114081, 60115398, 60115379, 60115379, 60115653, 60115657, 60115657, 60116531, 60116541, 60116542, 60116563, 60116599, 60116601, 60116658, 60116897, 60118838.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por B Braun Medical Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    367
  • Fecha
    2001-12-19
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    The above infusion pump may leak due to inadequate glue connection of the tube to the bottom of the drip chamber. the manufacturer initiated a correction by letter dated 10 october 2001. the firm did not provide any information to ecri.
  • Acción
    Make sure you have received the letter dated October 10, 2001 from B. Braun Medical. Identify and isolate any product in your inventory. For more information, contact B. Braun Medical by phone at (1610) 691-5400, USA. Or contact your local representative.

Device

Infusion Pump, Intravascular Gravity Management Equipment: (1) Baxter Compatible Primary ADDitIV,...

Manufacturer

B Braun Medical Inc
  • Source
    ANVSANVISA