Events

Alerte De Sécurité sur EQUIPMENT CASSETTE FOR DPA WITH CYCLING MACHINE HOMECHOICE. Reg. ANVISA: 10068390201.

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 Baxter Hospitalar 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
    935
  • Date
    2008-08-22
  • 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 the company, a possible cause for the problem would be the new arrangement of the units in the product boarding box (carton), which can cause folds in the tubes and consequently cause the alarm to occur. low temperature of the environment (where the therapy is performed) is also a factor that may be related to the occurrence of the alarm.
  • Cause
    The product registration holder has identified an increase in the number of patient calls related to the alarm occurrence 163 - "reinstall cassette".
  • Action
    Baxter sent out letters of communication to its clients, reporting on the problem and advising on the actions to be taken. Recommended actions are as follows: (1) If the therapy is being performed or the cassettes are stored in a cold place (less than 10 ° C), place the cassette in the heater bag 30 to 60 minutes before starting therapy ; (2) when reloading the cassette, when the machine shows "Reinstall Cassette", press "STOP" to silence the alarm, close all tongs, open the door, remove the cassette and reinstall it; (2) Hold the tubes aligned with their outlet position facing back and forth while closing the door, open the clamps and press "GO"; (3) When the display reads "Connect Bags", press "GO". This completes the filling procedure; (4) If the alarm repeats, replace the cassette with a new one; (5) Check that the temperature setting is 37 ° C - select this value if it is not; (6) If the error persists, contact the product registration holder.

Device

EQUIPMENT CASSETTE FOR DPA WITH CYCLING MACHINE HOMECHOICE. Reg. ANVISA: 10068390201.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA