Events

Safety Alert for Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA Registration Number: 10390690089 Hazard Class: III Model Affected: HCU 40 Serial Numbers Affected: 90440288 and 90440289

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA..

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
    2257
  • Date
    2017-04-03
  • 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
    • Upgrading your HCU 40 systems must be performed by Maquet's authorized service personnel in accordance with Upgrade Instruction - FSCA-2016-11-30 - Heating-Cooling Unit HCU 40 (MCV-UI-10000833-EN- 01) as soon as possible. • Complete the attached Recognition Form and return it as soon as possible to your local Maquet representative. • Incorporate the new cleaning and disinfection procedures into your operation processes, and perform any necessary training. • Continue to monitor hygiene (levels of contamination) according to your internal practices. • Immediately report any contamination findings to your local Maquet representative by filing a complaint.
  • Reason
    Maquet cardiopulmonary, as well as different competent national authorities, received isolated reports indicating bacterial contamination in the hcu 40 system water, including mycobacterial counts. maquet has not received any reports that a mycobacterial infection has been caused by a hcu 40. our investigations have shown that the currently published disinfection procedure of the hcu 40 system waterways (in the instructions for use) should be improved as to effectiveness against atypical mycobacteria. in this context, it is important to know that a hazard to the patient due to escape of microorganisms during the operation of the heating-cooling unit hcu 40 can be excluded with near absolute certainty. an independent testing institute also concluded that.
  • Action
    Field Action Code FSCA-2016-11-30 triggered under the responsibility of the company MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA. Company will make correction in the field.

Device

Hypothermia / Hypertemia System HCU 40 Technical Name: Body Temperature Control Equipment ANVISA ...

Manufacturer

MAQUET CARDIOPULMONARY DO BRASIL INDUSTRIA E COMERCIO LTDA.
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA