| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00104-1 |
| Product Name/Description |
MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
All devices affected
ARTG Number: 179104 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
5/02/2013 |
| Responsible Entity |
|
| Reason/Issue |
Maquet has identified two potential issues with the HL30 device which will be addressed in a software upgrade. First, in rare instances, as a result of an accidental impact or bump to the pump head cover, the unit may stop. This stoppage is intended to occur by design whenever the pump head cover is opened during operation. However if it occurs due to a rapid impact, the unit may stop without an informational message explaining the reason for the stoppage.
Secondly, in a limited number of cases, the unit slave pump did not engage after Cardioplegia pause. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Maquet is advising that if the unit stops, it can be reset by turning the potentiometer to zero. If the software anomaly with the cardioplegia module was to occur, the patient can be cross-clamped until the unit restarts, or transferred to another device. A Maquet Australia representative will be in contact with relevant staff at affected facilities to schedule the implementation of the corrective action. |
| Contact Information |
07 3339 3900 - Maquet Regulatory Affairs |