Events

Alerta De Seguridad para RAPIDPOINT 500 SYSTEM; Registration 10345161877, Serial Nos: 33897; 34218; 34225; 34227; 34516; 34502; 34515; 34497; 34607; 34608; 34611; 34975; 34990; 34982; 34977; 34974; 34986; 35098; 35097; 35096; 35664; 35671; 35669; 35667; 35672; 35666; 35729; 35680; 35728; 35726; 35724; 35979; 36044; 36601; 36604; 36603; 36693; 36697; 36683; 36639; 36819; 36814; 36813; 36818; 36812; 36811. (Annex 1)

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics 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
    1676
  • Fecha
    2015-08-27
  • 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
    The record holder informs that duplicate or missing analyte as described above, poses no health risk. The results are readily available in the instrument for consultation and referral to the HIL. The health risk is limited to the extremely unlikely situation in which an analyte when being analyzed is switched between two patients. A transfected result of sodium, potassium, glucose, lactate, carboxyhemoglobin, methaemoglobin, or neonatal bilirubin may lead to a potential health risk when the actual value is critical. In all cases, the probability of occurrence is extremely unlikely due to the low frequency of occurrence of the software problem and correlation with the clinical presentation of the patient, history and laboratory tests.
  • Causa
    For users who have enabled dual-port lis transmission on the rapidpoint 500 system, siemens healthcare has identified that when both the serial and ethernet ports are configured to transmit data, the flow of data from a port can affect potentially the other's data stream.
  • Acción
    The company advises that if the system is configured with Dual LIS transmission enabled, one of the ports (Serial or Ethernet) needs to be disabled. More information in the Letter to the Client (Annex 2).

Device

RAPIDPOINT 500 SYSTEM; Registration 10345161877, Serial Nos: 33897; 34218; 34225; 34227; 34516; 3...

Manufacturer

Siemens Healthcare Diagnósticos S.A.; Siemens Healthcare Diagnostics Inc
  • Empresa matriz del fabricante (2017)
    Siemens Ag
  • Source
    ANVSANVISA