| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00917-1 |
| Product Name/Description |
Heater Unit HU 35
All Models and Serial Numbers
ARTG Number: 144010 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
25/07/2017 |
| Responsible Entity |
|
| Reason/Issue |
Getinge has released revised disinfection procedure for Heater Unit HU 35. Heater Unit HU 35 is used during extracorporeal life support (ECLS) in intensive care units to maintain the patient’s blood temperature via an oxygenator heat exchanger. There is no contact between the blood stream of the patient and the system water circulating through the heat exchanger.
Maquet Cardiopulmonary as well as different National Competent Authorities have received isolated reports confirming the presence of bacterial contamination in the system water of HU 35 including mycobacterial counts.
However, Maquet Cardiopulmonary has not received any reports that a mycobacterial infection or any other bacterial infection would have been caused by a Heater Unit HU 35. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The current published Instructions for Use chapter 6 “Cleaning and Disinfection” for HU 35 Heater Units will be replaced by a new Instructions for Use (IFU).
Action to be taken by the user:
1. Complete and return the enclosed Acknowledgement Form as soon as possible to your local Maquet representative;
2. Incorporate this revised procedure into your operating processes;
3. Conduct any training necessary for the revisions;
4. Continue to monitor the hygiene (contamination levels) in accordance with your internal practices;
5. Immediately report any contamination findings to your local Maquet representative by a complaint; and
6. Remind all users that the HU35 is not to be opened or filled in the operating room.
This action has been closed out on 25/07/2019 |
| Contact Information |
1800 605 824 - Maquet Customer Service |