Events

Alerte De Sécurité sur 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.

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 Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics 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
    2097
  • Date
    2016-09-15
  • 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
    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.
  • Cause
    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.
  • Action
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA