Events

Safety Alert for BALLOON INTRA-AORTIC CS100 AND CS300. ANVISA Registry: 10390690062.

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

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
    1403
  • Date
    2014-07-25
  • 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
    A deformable retention ring for specific BBIAs (System 98 / 98XT, CS100 / CS100i and CS300) can be moved within the fan structure causing it to stop spinning and, as a result, cause the power supply to overheat. Overheating the source may cause the system to shut down without any warning or visual warning. A sudden cessation of therapy may result in unstable hemodynamic instability. At the moment the Intra-aortic balloon pumps at risk mentioned in this field action may be used, however the above mentioned precautions (see field Description of Action) must be observed until MAQUET performs the repair of the products.
  • Reason
    The fan structure of the device may contain a deformed retaining ring, which may lead to overheating of the power supply and consequent sudden shutdown.
  • Action
    The company is planning to replace the fan structure. Users are advised to: - not leave the patient alone during intra-aortic balloon pump (BBIA) therapy; - The balloon should not remain inactive in the patient for more than 30 minutes due to the potential for thrombus formation. - If thrombus occurs, transfer the patient to an alternative BBBIA or manually inflate the Intra-aortic Balloon with air or helium and aspirate immediately.

Device

BALLOON INTRA-AORTIC CS100 AND CS300. ANVISA Registry: 10390690062.

Manufacturer

Datascope Corp.
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    ANVSANVISA