| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00978-1 |
| Product Name/Description |
PLEGIOX Cardioplegia Heat Exchanger
All Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets.
Reference Numbers: 703006246, 703006285, 703006317
ARTG Number: 158781 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
8/08/2017 |
| Responsible Entity |
|
| Reason/Issue |
The PLEGIOX heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegia and / or crystalloid cardioplegia solutions during extracorporeal circulation.
The PLEGIOX heat exchanger consists of two liquid circulations strictly separated from each other by a separating barrier to separate both liquids from each other and to effect thermal transfer at the same time; the design of the PLEGIOX uses hollow fibres made of polyurethane. Hollow fibres serve as barrier separating the circulating liquids while effecting thermal transfer.
Maquet Cardiopulmonary GmbH (MCP) internal investigations have revealed that the specification of the Performance Factor (PF) at flow rates of 1 litre per minute is not always maintained as defined in Instruction for Use (IFU). Deviations up to minus 20% were identified during in-house testing.
Zero adverse events have been reported in relation to this insufficiency. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Getinge seeks to notify users that:
When using the PLEGIOX, the flow rate should be no higher than 500 ml/min to ensure reasonable performance.
This action has been closed out on 10/07/2019 |
| Contact Information |
1800 438 464 - Getinge Customer Service |