Events

Alerte De Sécurité sur MARS Treatment Kit, registration no. 80134860075.

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 TERAKLIN A G.

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
    838
  • Date
    2006-09-18
  • 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 Gambro Rostock, no injuries were reported in patients, however, there is a possibility of indirect loss of body fluid from the patient, caused by loss of albumin in the waste from the dialysis process. Specifically, this may be the case when the customer sets the low pressure alarm setpoint to too low relative to the current pressure too low. Inquiries or clarifications, please contact the company responsible for the product: GRIFOLS DO BRASIL LTDA (41) 3668-2444.
  • Cause
    Possibility of ruptures in the pump segment within the mars albumin circuit.
  • Action
    Material quality controls were implemented to avoid recurrence of this type of event. In addition, the tube manufacturing process was optimized in 2005, resulting in significantly higher and longer lasting stability of the pump segment. To exclude any remote risk to patient health, in the event of pump segment ruptures, Gambro Rostock instructs all customers that "To manually change the pressure alarm set point, make sure that the difference between the current pressure and the lower alarm set point does not exceed 100 mmHg. "

Device

MARS Treatment Kit, registration no. 80134860075.

Manufacturer

TERAKLIN A G
  • Source
    ANVSANVISA