Events

Alerte De Sécurité sur Enteral Nutrition Equipment for use with Macrogotas Infusion Pump, Hazard Class II, Brand: Baxter, Registro: 80145240369 .. Serial Numbers: SEE ANNEX - DISTRIBUTION LIST

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.; Baxter Healthcare SA Singapure Branch..

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
    1507
  • Date
    2014-12-16
  • 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
    As described in the Instructions for Use of the Colleague Pump, they are able to infuse medications, solutions, parenteral nutrition, lipids, blood and blood components. It is important to note that, according to the manufacturer, the Colleague Infusion Pump is NOT designed for enteral administration (SEE CUSTOMER LETTER). /// According to the manufacturer's information there is no risk to patients of injuries. A failure in the amount of solution administered may occur due to flow failure during administration. In this case the patient may present with adverse symptoms such as abdominal distension, diarrhea and hyperperistalse.
  • Cause
    Identified by the company the incomplete validation of the equipment according to the requirement contained in the specifications of the colleague infusion pump. in this case, flow rate and volume may fail during enteral use. in use, it is also possible to have faults in closing the flow control valve of the colleague pump (code 808: 03).
  • Action
    The company issues a safety alert to customers stating that when using the Colleague Infusion Pump teams, appropriate medical follow-up should be requested. Customers listed on the distribution map (SEE ANNEX), must fill out the Customer Response Form (SEE CLIENT LETTER) and send the company. In case of being a distributor, the orientation is to pass the Letter of clarification to your customers who have purchased the material.

Device

Enteral Nutrition Equipment for use with Macrogotas Infusion Pump, Hazard Class II, Brand: Baxter...

Manufacturer

Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch.