Events

Alerte De Sécurité sur FLO-GARD VOLUMETRIC INFUSION PUMP. MODELS 6200, 6201, 6300 AND 6301 .. RISK CLASS III.

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
    881
  • Date
    2007-08-08
  • 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
    Baxter Hospital Ltda informs that the risks associated with absence of alarm when occlusion occurs above the flexible chamber of the infusion pump are: the return flow of the patient's blood, the loss of the infusion line or the non-administration of the drug to the patient. Still according to Baxter, the conditions that may potentially cause these situations are as follows: (1) when the vial or pouch has been emptied, but the pump continues to pump; (2) when the spike was not completely inserted into the bottle or pouch; (3) when a rigid bottle (glass bottle, for example) or semi-rigid bottle (Buretrol, for example) is improperly vented. In these cases, according to the addendum to the manual, specific prevention measures should be observed. Anvisa's Technovigilance Unit is monitoring this case.
  • Cause
    Infusion pump alarm may not work when occlusion occurs above the flexible chamber of the equipment.
  • Action
    Baxter Hospitalar do Brasil Ltda has already located the customers involved and has forwarded to them an addendum to the equipment operation manual. This addendum informs about the possibility that the pump does not alarm when there is occlusion above the flexible chamber, defines the situations in which this problem may occur and indicates the additional precautions to be observed.

Device

FLO-GARD VOLUMETRIC INFUSION PUMP. MODELS 6200, 6201, 6300 AND 6301 .. RISK CLASS III.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA