Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by B Braun Medical Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    367
  • Date
    2001-12-19
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    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.
  • Action
    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