Events

Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par B Braun Medical Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    367
  • Date
    2001-12-19
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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