Events

Alerta De Seguridad para Infusion Pump, Intravascular Gravity Management Equipment: (1) Key, (2) Horizon Key, (3) Primary Key ADDitIV, (4) Horizon Primary ADDitIV, (5) Primary ADDitIV, (6) SafeLine Horizon, ) SafeSite Horizon, (8) Ultrasite, (9) Ultrasite Horizon, (10) Ultrasite View, (11) View. Catalog Nos .: CC1270, CC1271, CC1290, CC3130, CC3130-SP0, CC3230, CC6413, NF1250, NF3140, NF3140-10, 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 .: 60202059, 60204396, 60204396, 60204396, 60206655, 60206655, 60201171, 60211414, 60213590, 60213590, 60213594, 60218860, 60218346, 60218349, 60218373, 60218607, 60219461, 60219481, 60221910, 60223949, 60223965, 60223973, 60223976, 6024430, 60230296, 60230296, 60223036, 60223036, 60223036, 60230342, 60235822, 60235929, 60236775, 60236775, 60243610, 60243109, 60243129, 60243132, 60243132, 60243135, 60243136, 60243138, 60243583, 60243586, 60243588, 60243599, 60244153 to 60244155, 60244180, 60244514, 602445149, 602445149, 602445169, 602445169, 602445169, 602445169, 602445169, 602445409, 602445409, 602445169, 602445169, 602445169, 602445169, 60255960, 60255930, 60255930, 60255930, 60255930, 60255960, 60255960, 60255960, 60255960, 60255960, 60255960, 60255910, 60255310, 60255310, 60255310, , 60256167, 60256167, 60256177, 60256177, 60256147, 60256147, 60256147, 60256147, 60256157, 60256157, 60256162, 60257354, 60257373, 60258119, 60258158, 60258159, 60258169, 60258163, 60258167, 60258168, 60259837, 60259868, 60260586, 60260587, 60260592, 60260594, 60260607, 60261961, 60261976, 60261976, 60261976, 60261917, 60262821, 60262839, 60262839, 60262849, 60262819, 60263719, 60263724, 60263725, 60263252, 60263859, 6026455, 60264606, 60264609, 60264613, 60264614, 60264620, 60265844, 60265845;

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
    397
  • Fecha
    2002-02-22
  • 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 infusion pump management set above may disconnect from the drip chamber. the manufacturer initiated the correction by letter dated 10 october 2001. the firm did not provide any information to ecri.
  • Acción
    Verify that you received the letter dated 10 October 2001 from B. Braun Medical. Identify and isolate any affected product in your inventory. For more information, contact B. Braun Medical at (1610) 691-5400 or your local B. Braun Medical representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

Infusion Pump, Intravascular Gravity Management Equipment: (1) Key, (2) Horizon Key, (3) Primary ...

Manufacturer

B Braun Medical Inc
  • Source
    ANVSANVISA