| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01408-1 |
| Product Name/Description |
CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
ARTG Number: 94208
(LivaNova Australia Pty LtdCirculatory assist unit, pump, centrifugal) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
13/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
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.
This action has been closed out on 22/10/2018 |
| Contact Information |
03 9799 7444 - LivaNova Australia |