Events

Alerte De Sécurité sur ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 Hazard Class: II Affected Model: ADVIA Chemistry XPT Affected Batch / Serial Numbers: CA1275001020102; CA1275001600160; CA1275001630163

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
    2096
  • Date
    2016-09-12
  • 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
    In order to avoid any possibility of inconsistent ISE results due to disconnected electrodes, make sure that the electrodes are fully connected after replacement, washing or maintenance activities by performing ISE calibration and processing of Quality Controls. If the electrode is not connected properly, the calibration will fail and the operator should perform the usual troubleshoot procedures. Perform the 2 levels of Quality Control at least once a day to confirm the perfect performance of the system.
  • Cause
    It is possible that the ise module will exhibit discrete unbonded results for sodium, potassium and chlorine when the respective electrode (including the reference electrode) remains switched off after replacement, washing or maintenance activities. the calibration and the 2 levels of quality control will fail if the electrode stays off. the instructions for use (ifu) for the ise electrodes clearly state the need to calibrate the ise after the replacement and processing of the two levels of control before testing the patient samples. after the special maintenance - wash, the online help documentation clearly informs the need to calibrate and process controls.
  • Action
    Field Action Code CHI 15-03 triggered under the responsibility of the company Siemens Healthcare Diagnósticos SA Company will notify the client.

Device

ADVIA Chemistry XPT Technical Name: Biochemical Analyzer ANVISA Registration Number: 10345161947 ...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA