Events

Alerte De Sécurité sur RAPIDLab 1200 SYSTEMS - Registration No. 10345160455; RAPIDPoint 400 Series - Registration No. 10345160460; RAPIDPoint 500 SYSTEM - Registration No. 10345161877. Serial numbers attached to the alert.

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 Ltda..

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
    1313
  • Date
    2013-10-16
  • 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
    According to the company's statement, mistakes in identifying the sample may lead to the release of incorrect patient results and inappropriate treatment. The clinical results of blood gas analyzers are not interpreted in isolation and inadequate conduct is rare since the physician, through other findings, knows the expected result. Blood gas analyzers are employed in clinical practice and the tests are used to correlate clinical and biochemical findings with optimal treatment and conduct to the patient. Changes in therapy, such as oxygenation rate, would be followed by a repeat test. Patient monitoring would also alert the physician to the potentially discordant outcome, preventing the occurrence of harm.
  • Cause
    Siemens has identified that users may inadvertently enter a wrong patient id on the demographic data editing screen on the rapidpoint® 400, rapidpoint® 500 or rapidlab® 1200 series blood gas analyzers, which could ultimately lead to to an error in the identification of the sample.
  • Action
    To mitigate misidentification, Siemens directs its customers to remove the Patient List button selection; to check demographic data before leaving the demographic data editing screen, to enable only barcode entry, and to keep the letter with the laboratory records. In addition, a mandatory software update must be performed according to the availability of the software.

Device

RAPIDLab 1200 SYSTEMS - Registration No. 10345160455; RAPIDPoint 400 Series - Registration No. 10...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA