Events

Alerta De Seguridad para Trade name: RAPIDPoint 400 Series; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1200 SYSTEMS Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345160460; 10345161877; 10345160455 Hazard Class: II Affected Model: RAPIDPoint 400; RAPIDPoint 400; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1240; RAPIDLAB 1245; RAPIDLAB 1260; RAPIDLAB 1265 Batch / serial numbers affected: 9884; 9895; 11849; 11870; 12752; 12679; 12680; 12751; 9740; 36819; 34225; 35098; 35664; 35667; 34608; 34611; 35096; 35097; 35669; 35671; 35672; 35728; 35979; 36044; 36601; 36942; 36946; 37131; 37133; 37175; 37177; 37180; 37182; 37185; 37188; 37674; 37683; 37686; 37851; 37852; 37853; 34218; 34497; 34502; 34515; 37102; 34516; 34729; 36683; 36697; 37132; 37140; 37678; 37689; 37838; 37839.

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
    2097
  • Fecha
    2016-09-15
  • 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
    Siemens recommends that you do not configure the Analyzer with patient demographics (surname, first name) disabled and the quick sample identification option enabled. If sample IDs are scanned on the analysis screen, confirm that the patient ID is correct on the screen prior to sample analysis. Correct patient identification on the analysis screen if it is incorrect.
  • Causa
    Siemens healthcare diagnostics has determined that when all of the following steps occur there is a potential for the first name and / or surname of a patient to be printed with the identification and results data of a different patient, even if those fields have been disabled in the system . · 1. the blood gas analyzer is configured with the patient's personal data (surname, first name) disabled and the quick sample identification option (query host used to retrieve the patient's personal data fields in the data management system ) is enabled. · 2. a bar code with incorrect patient identification is scanned in the analysis screen before the sample is analyzed. · 3. incorrect identification of the patient and last name displayed on the analysis screen are not confirmed and corrected. · 4. the sample is analyzed and the correct identification of the patient is digitized or entered on the personal data screen by the operator. the patient identification the result of the analysis, however, are correct on the analyzer screen and the lis. only the printout may contain the incorrect first or last name, which should not have been pressed, since those fields were disabled in the configuration.
  • Acción
    Field Action Code POC 16-021 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will send Letter to the Client.

Device

Trade name: RAPIDPoint 400 Series; RAPIDPOINT 500 SYSTEM; RAPIDLAB 1200 SYSTEMS Technical Name: B...

Manufacturer

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