Events

Recall of CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by LivaNova Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2017-RN-01408-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-11-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01408-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    During internal testing, livanova identified that there is a possibility that the automatic line closure by the erc clamp after detection of an air bubble could take longer than is intended by design in the cp5 system. this could lead to the remote possibility of an air bubble reaching a patient before the clamp closes if the blood flow rate is high and the distance between the bubble sensor and the patient is set at the minimum required by the ifu (1 metre). to date, livanova has not received any reports that an air bubble has passed the erc clamp, nor have there been any reports of patient injury associated with this issue.
  • Action
    LivaNova is advising users to ensure an arterial filter is used to reduce the probability of air ingress to the patient's bloodstream. LivaNova will be installing a firmware upgrade as a permanent correction.

Device

CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
  • Model / Serial
    CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017ARTG Number: 94208 (LivaNova Australia Pty LtdCirculatory assist unit, pump, centrifugal)
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd