| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00511-1 |
| Product Name/Description |
Essenz - Heart-lung bypass system
Software Revision Number: 1.4 or earlier
Essenz REF 49-00-10
Serial numbers: 49PK00073, 49PK00072, 49PK00105, 49PK00106, 49PK00130, 49PK00116, 49PK00117, 49PK00119, 49PK00235, 49PK00234
ARTG 392694
(LivaNova Australia Pty Ltd - Heart-lung bypass system) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/06/2024 |
| Responsible Entity |
|
| Reason/Issue |
Reports of incorrect Cardioplegia (CPL) Dose Tracking Counters displayed on the LivaNova Essenz HLM cockpit have been received. This may occur when the cardioplegia module executes an unexpected reset while the cardioplegia dose is being delivered. The problem may result in the dose tracking counter not being restored with the correct status and volumes, although the actual delivered volume to the patient remains correct.
In the event of an incorrect Cardioplegia Dose Tracking Counters display, the machine always delivers the correct volume. The cardioplegia volume is continuously monitored during the surgery. The missing volume in the drug bag clearly shows the amount administered, so any sudden jumps in the counter is obvious to the user. The potential harm, if the perfusionist relies on the incorrect display counter, is myocardial damage.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
The software update, HLM Version 1.4.1, has been implemented to solve the cardioplegia dose tracking counter behaviour. All affected customers have received the update. |
| Contact Information |
1800 452 650 - LivaNova Customer Service |