Events

Safety Alert for MARS Treatment Kit, registration no. 80134860075.

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

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
    838
  • Date
    2006-09-18
  • 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 Gambro Rostock, no injuries were reported in patients, however, there is a possibility of indirect loss of body fluid from the patient, caused by loss of albumin in the waste from the dialysis process. Specifically, this may be the case when the customer sets the low pressure alarm setpoint to too low relative to the current pressure too low. Inquiries or clarifications, please contact the company responsible for the product: GRIFOLS DO BRASIL LTDA (41) 3668-2444.
  • Reason
    Possibility of ruptures in the pump segment within the mars albumin circuit.
  • Action
    Material quality controls were implemented to avoid recurrence of this type of event. In addition, the tube manufacturing process was optimized in 2005, resulting in significantly higher and longer lasting stability of the pump segment. To exclude any remote risk to patient health, in the event of pump segment ruptures, Gambro Rostock instructs all customers that "To manually change the pressure alarm set point, make sure that the difference between the current pressure and the lower alarm set point does not exceed 100 mmHg. "

Device

MARS Treatment Kit, registration no. 80134860075.

Manufacturer

TERAKLIN A G
  • Source
    ANVSANVISA