Events

Safety Alert for Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions into infusion pumps) - Code 441702 - Registration 80136990755 - Lots 15G21LA335, 15H21LA383, 15H21LA384, lSH24LA385 and 15H31lA398 and Enteral Nutrition Equipment for infusion pumps B.Braun (Infusomat Space Set Enteral Air) Code 402111 - Registration number 80136990733, lot 15H2SLA388

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Laboratórios B. Braun S.A..

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
    1697
  • Date
    2015-10-09
  • 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
    According to the manifestation of the company, this condition can compromise the correct functioning during the removal of the pump equipment, which can result in free flow, in case the health professional does not perform the standard procedure, which consists of closing the clamp and disconnect the patient's equipment before removing it from the pump.
  • Reason
    During an inspection by the production supervisor (assembly area), the erroneous assembly of the green infusomat clamp component was identified by a specific employee. although the employee was trained, he was assembling the tongs inverted. 100% of the employee's production was inspected and the problem was confirmed.
  • Action
    The company is carrying out the collection of the lots mentioned in this alert and requests the interruption of the use of said batches, the segregation thereof, as well as the information to the B. Braun SA laboratories of the quantities of existing units of each batch number for the process of recollection

Device

Infusomat Space Set Air IL (Non-photosensitive equipment for infusion of parenteral solutions int...

Manufacturer

Laboratórios B. Braun S.A.