Events

Alerte De Sécurité sur 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)

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
    1676
  • Date
    2015-08-27
  • 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
    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.
  • Cause
    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.
  • Action
    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
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    ANVSANVISA