Events

Alerte De Sécurité sur BALLOON INTRA-AORTIC CS100 AND CS300. ANVISA Registry: 10390690062.

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 Datascope Corp..

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
    1403
  • Date
    2014-07-25
  • 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
    A deformable retention ring for specific BBIAs (System 98 / 98XT, CS100 / CS100i and CS300) can be moved within the fan structure causing it to stop spinning and, as a result, cause the power supply to overheat. Overheating the source may cause the system to shut down without any warning or visual warning. A sudden cessation of therapy may result in unstable hemodynamic instability. At the moment the Intra-aortic balloon pumps at risk mentioned in this field action may be used, however the above mentioned precautions (see field Description of Action) must be observed until MAQUET performs the repair of the products.
  • Cause
    The fan structure of the device may contain a deformed retaining ring, which may lead to overheating of the power supply and consequent sudden shutdown.
  • Action
    The company is planning to replace the fan structure. Users are advised to: - not leave the patient alone during intra-aortic balloon pump (BBIA) therapy; - The balloon should not remain inactive in the patient for more than 30 minutes due to the potential for thrombus formation. - If thrombus occurs, transfer the patient to an alternative BBBIA or manually inflate the Intra-aortic Balloon with air or helium and aspirate immediately.

Device

BALLOON INTRA-AORTIC CS100 AND CS300. ANVISA Registry: 10390690062.

Manufacturer

Datascope Corp.
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    ANVSANVISA