Events

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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda.; Baxter Healthcare SA Singapure Branch..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1507
  • Date
    2014-12-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.