Events

Recall Or Safety Alert for CP5 centrifugal pumps used in combination with Livanova heart-lung machines (HLM), manufactured before February 10, 2017.

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by N/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
    Recall / Safety Alert
  • Date
    2017-10-31
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 recall data from the U.S. and Spain.
  • Extra notes in the data
  • Action
    Safety warnings in relation to the possibility that the automatic closing of the line by the electronic remote control clamp (ERC) after an air bubble is detected could take longer than expected in the CP5 system and firmware update of the CP5 control panels, HLM bubble sensors and E / A blocks (EP pack) to avoid the problem.

Device

CP5 centrifugal pumps used in combination with Livanova heart-lung machines (HLM), manufactured b...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI