Alerte De Sécurité sur SARNS ASSISTED CIRCULATION SYSTEM BATTERIES - Registration 80012280010 - Models 9490 and 9491.

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 TERUMO MEDICAL DO BRASIL 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
    1196
  • Date
    2012-11-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • 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
    If the Centrifuge System malfunctions during cardiopulmonary bypass, the risk to the patient ranges from insignificant to severe, and depends on: • the patient's condition; • how quickly the user responds to malfunction. If used as the arterial pump, a defect can result in: • Loss of arterial flow. The patient's resulting damage can range from a temporary and well-tolerated reduction in blood pressure to cell death, resulting in neurological dysfunction, cardiac dysfunction due to inadequate myocardial circulation, end-organ dysfunction, or death in the event of a long period of no flow; • Reflux condition. This could result in: exsanguination of the patient leading to hypovolemia; entrainment of the air at the site of the aortotomy leading to a surgical intervention to remove the air to prevent neurological or end organ damage or dysfunction. If the system is used for assisted venous drainage (an infrequent application), a defect may result in: • inadequate venous drainage. This can lead to hypoperfusion if venous drainage is insufficient to maintain adequate blood flow. Any malfunction can result in user distraction and a potential delay of the process.
  • Cause
    Malfunction of the battery backup system for sarns ™ centrifuge system.
  • Action
    Observe carefully the instructions contained in the Appendix - Letter to Customers.

Manufacturer