| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01600-1 |
| Product Name/Description |
HICO - Variotherm 550 Hypothermia/Hyperthermia Unit
Previous ARTG number: 265557 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
13/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has come to the attention of Maquet Australia that the HICO-Variotherm 550 Hypothermia/Hyperthermia Unit has been supplied under the incorrect intended purpose of heat exchange control unit for Extra Corporeal Membrane Oxygenation. As described in the operating instructions document supplied with the device, the Variotherm is solely intended for the cooling or heating of water mats used to cool or warm a patient. Utilising the Variotherm for heat exchange control across a gas exchange membrane in Extra Corporeal Membrane Oxygenation (ECMO) is against the intended use of the device and is incompatible with Maquet oxygenators due to the associated cleaning procedures outlined in the user manual of the Variotherm unit. In particular the germicidal agent (Sanosil, Hydrogen Peroxide) that is recommended to be added to the tank water after the final flush (prior to use) is not suitable for use with Maquet oxygenators. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Customers are advised to ensure that the intended purpose as indicated in the user manual is being complied with at their facilities. Maquet is offering to replace the Variotherm with units with an ECMO indication and customers are advised to contact their Maquet representative to arrange the replacement, if needed.
This action has been closed out on 19/10/2018 |
| Contact Information |
1800 605 824 - Maquet Customer Service |