Events

Avis De Sécurité sur Siemens BCS / BCS XP System

Selon Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Slovenia qui a été fabriqué par Siemens Healthcare Diagnostics Products GmbH..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Pays de l'événement
    Slovenia
  • Source de l'événement
    AMPMDRS
  • Notes / Alertes
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
  • Notes supplémentaires dans les données
  • Cause
    Siemens healthcare diagnostics has observed that in very rare cases false short clotting times for pt on bcs and bcs xp with dade innovin can occur. this has also an effect for false high pt % of the norm or false low pt inr values. these false short clotting times were observed with turbid, hemolytic and/or icteric samples from intensive care patients. the corresponding reaction curves of these rare samples showed a pre- peak, which can lead to falsely short clotting time. in rare cases the result was not flagged by the existing check algorithms. an example is given in figure 1. (left: expected reaction curve; right: erroneous evaluated reaction curve). .

Device

Siemens BCS / BCS XP System
  • Modèle / numéro de série
    BCS 10454728 (BCS RECONDITIONED) 10454729 (BCS RECONDITIONED) 10454742 (BEHRING COAGULATION SYSTEM) 10459303 (BCS RECONDITIONED) 10460659 (BCS INSTRUMENT) 10461881 (BCS INSTRUMENT) BCS XP 10459330 (BCS XP SYSTEM, COMPLETE) 10462449 (BCS XP ANALYZER SYSTEM) 10461894 (BCS XP) 10470625 (BCS XP REFURBISHED) Dade Innovin 10284500 10445704 10445705 10445706 10465673 10465674
  • Manufacturer
    Siemens Healthcare Diagnostics Products GmbH.

Manufacturer

Siemens Healthcare Diagnostics Products GmbH.
  • Société-mère du fabricant (2017)
    Siemens Ag
  • Source
    AMPMDRS